Sigma Diagnostics, Inc.
Sigma Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 2002.
Top product codes for Sigma Diagnostics, Inc.
Recent clearances by Sigma Diagnostics, Inc.
1–100 of 164- K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
- K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
- K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
- K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
- K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
- K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B
- K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
- K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540
- K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
- K003328 — ACCUCLOT CONTROL I, MODEL A4089
- K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
- K001403 — SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
- K993741 — EZ LDL CHOLESTEROL TEST SYSTEM
- K001569 — INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
- K000527 — ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
- K000528 — ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
- K992711 — SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
- K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
- K992798 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
- K992800 — SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
- K992801 — SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
- K992803 — SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
- K984574 — INFINITY GLUCOSE REAGENT
- K982209 — ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
- K982251 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
- K982236 — SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
- K981248 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
- K981254 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
- K981255 — SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
- K980667 — INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
- K980666 — INFINITY AST REAGENT (PROCEDURE NO. 51)
- K973274 — ACCUCOLOR HIGH CALIBRATOR (A3089)
- K972260 — CS-400 COAGULATION ANALYZER SYSTEM (A1208)
- K972796 — SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
- K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
- K972743 — SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
- K972794 — DIGOXIN DG-II FPIA REAGENT SET
- K972132 — SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS
- K972144 — SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
- K972041 — EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
- K963535 — SIGMA DIAGNOSTICS GLUCOSE REAGENT
- K963539 — SIGMA DIAGNOSTICS WASH CONCENTRATE
- K963543 — SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
- K963533 — SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
- K963537 — SIGMA DIAGNOSTICS BUN REAGENT
- K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT
- K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
- K963536 — SIGMA DIAGNOSTICS CALICIUM REAGENT
- K963534 — SIGMA DIAGNOSTICS CREATININE REAGENT KIT
- K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
- K963542 — SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
- K960875 — KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
- K955720 — AMAX CS-190 COAGULATION ANALYZER SYSTEM
- K955724 — KC 1A COAGULATION ANALYZER/SET
- K955735 — KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
- K954840 — ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
- K955716 — VANCOMYCIN FPIA REAGENT SET
- K952557 — TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
- K954839 — ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
- K951584 — ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
- K933934 — GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
- K945908 — GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
- K950028 — PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
- K942908 — IGM RF EIA
- K943291 — ANTI DS-DNA
- K943550 — GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
- K943866 — VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
- K944063 — FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
- K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
- K943313 — PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
- K935984 — GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
- K940840 — ACT CONTROL SET
- K940569 — DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
- K942192 — THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
- K932603 — APOLIPOPROTIEN B (APO B)
- K932606 — APOLIPOPROTIEN A-1 (APO A-1)
- K935308 — ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
- K941085 — LIPASE-PS ASSAY PROCEDURE NO. 805
- K935057 — FACTOR VIII DEFICIENT PLASMA
- K935054 — FACTOR X DEFICIENT PLASMA
- K935056 — FACTOR VII DEFICIENT PLASMA
- K935058 — FACTOR
- K933425 — AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
- K932517 — IRON/UIBC REAGENT
- K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
- K932067 — ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
- K930212 — THROMBOPLATIN-M WITH CALCIUM
- K915462 — FIBRINOGEN CONTROL
- K915380 — MICROPROTEIN-PR
- K915465 — DIGITOXIN FPIA REAGENT SET
- K915463 — ACTIVATED PARTIAL THROMBOPLASTIN TIME
- K915464 — DIGITOXIN FPIA CALIBRATOR SET
- K914777 — SIGMA PROCEDURE NO. 333-UV
- K913061 — FIBRINOGEN DETERMINATION KIT
- K913858 — AMYLASE REAGENT (PROCEDURE 577)
- K912061 — HEPARIN ADSORBENT
- K910741 — HEPARIN CONTROLS, HIGH AND LOW
- K910255 — FLOW CYTOMETRY FITC/PE COMPENSATION KIT
- K897147 — SIGMA PROCEDURE NO. 735
- K894204 — CALCIUM (ARSENAZO III) REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.