Instrumentation Laboratory CO
Instrumentation Laboratory CO holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2023, with 31 FDA device recalls on record.
Top product codes for Instrumentation Laboratory CO
FDA recalls by Instrumentation Laboratory CO
10 most recent of 31- Z-2485-2019 — ROTEM ex-tem; US Part No: 503-05-US
- Z-2487-2019 — ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
- Z-2486-2019 — ROTEM ex-tem Canada Part No: 503-05-CA
- Z-0077-2019 — Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
- Z-0895-2018 — Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
- Z-0736-2016 — HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
- Z-0832-2015 — HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
- Z-2066-2014 — ACL TOP 300 CTS, automated coagulation laboratory instrument.
- Z-2061-2014 — ACL TOP 700, automated coagulation laboratory instrument.
- Z-2064-2014 — ACL TOP 500 CTS, automated coagulation laboratory instrument.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Instrumentation Laboratory CO
1–100 of 321- K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
- K223187 — HemosIL Liquid Anti-Xa
- K223090 — GEM Premier ChemSTAT
- K223402 — HemosIL von Willebrand Factor Antigen
- K213464 — HemosIL Liquid Anti-Xa
- K213426 — HemosIL ReadiPlasTin
- K203790 — GEM Premier 5000
- DEN190032 — HemosIL Liquid Anti-Xa
- K200033 — HemosIL von Willebrand Factor Antigen
- K183546 — GEM Premier ChemSTAT
- K183549 — GEM Premier ChemSTAT
- K183555 — GEM Premier ChemSTAT
- K180486 — HemosIL Factor XII Deficient Plasma
- K173403 — GEM Premier 5000
- K172903 — HemosIL D-Dimer HS 500
- K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
- K170314 — ACL AcuStar
- K160225 — GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
- K160402 — GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
- K160412 — GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
- K160415 — GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
- K160885 — HemosIL D-Dimer HS
- K161818 — GEM Premier 3000
- K153137 — HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
- K160445 — HemosIL Silica Clotting Time
- K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
- K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- K151534 — HemosIL D-Dimer HS
- K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
- K132722 — HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
- K133407 — GEM PREMIER 4000
- K122584 — HEMOSIL READIPLAS TIN
- K112995 — GEM PREMIER 4000
- K113211 — HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
- K110031 — HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
- K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA
- K102552 — HEMOSIL LA POSITIVE CONTROL
- K102164 — HEMOSIL PROTEIN S ACTIVITY ASSAY
- K093623 — GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
- K091556 — HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
- K093737 — HEMOSIL F11 & FV DNA CONTROL
- K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
- K090264 — HEMOSIL D-DIMER HS 500, CONTROLS
- K090563 — HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
- K091980 — ACL TOP 700 LAS
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
- K083518 — ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
- K082859 — HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
- K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
- K073367 — HEMOSIL FIBRINOGEN-C
- K070927 — HEMOSIL D-DIMER HS
- K070005 — HEMOSIL RECOMBIPLASTIN 2G
- K070635 — HEMOSIL PROCLOT
- K070301 — HEMOSIL ANTITHROMBIN
- K063679 — ACL TOP
- K061598 — HEMOSIL HOMOCYSTEINE AND CONTROLS
- K061974 — GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
- K062430 — HEMOSIL PROTEIN C
- K062431 — HEMOSIL LIQUID ANTITHROMBIN
- K060931 — HEMOSIL PT-FIBRINOGEN HS PLUS
- K060688 — HEMOSIL SYNTHASIL
- K060162 — ACL ELITE; ACL ELITE PRO
- K053499 — HEMOSIL PROS
- K052121 — GEM PREMIER 3000
- K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA
- K050544 — HEMOSIL D-DIMER HS
- K050221 — HEMOSIL SILICA CLOTTING TIME
- K050278 — HEMOSIL D-DIMER
- K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA
- K042982 — QUANTEX MYOGLOBIN
- K043184 — HEMOSIL RECOMBIPLASTIN
- K042576 — COATEST SP FVIII
- K041905 — HEMOSIL CALIBRATION PLASMA
- K040879 — QUANTEX FERRITIN
- K040843 — HEMOSIL VON WILLEBRAND ACTIVITY
- K040359 — HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
- K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA
- K033414 — ACL TOP MODEL, TOP
- K033775 — HEMOSIL LIQUID ANTITHROMBIN XL
- K032663 — QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
- K033631 — MODIFICATION TO COATEST FACTOR VIII
- K032419 — QUANTEX D-DIMER
- K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA
- K030964 — CALIBRATION PLASMA LMW HEPARIN
- K030965 — CONTROL PLASMA LMW HEPARIN
- K031122 — HEMOSIL FACTOR X DEFICIENT PLASMA
- K030287 — HEMOSIL FACTOR XI DEFICIENT PLASMA
- K030215 — BIORAPID MONONUCLEOSIS
- K024082 — HEMOSIL FACTOR VII DEFICIENT PLASMA
- K023839 — HEMOSIL FACTOR V DEFICIENT PLASMA
- K023269 — HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
- K022158 — IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
- K022550 — COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
- K022195 — COAMATIC AT-400
- K021024 — HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
- K021022 — HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)
- K021023 — HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)
- K012901 — COLOR-MONOGEN
- K012768 — HEMOSIL RECOMBI PLASTIN
- K011424 — IL TEST PROS
Data sourced from openFDA. This site is unofficial and independent of the FDA.