American Dade
FDA 510(k) medical device clearances.
Top product codes for American Dade
Recent clearances by American Dade
1–100 of 149- K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
- K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
- K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
- K872789 — PARAMAX URINE/CSF CALIBRATOR
- K872195 — DATA-FI DIMERTEST LATEX ASSAY
- K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
- K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
- K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
- K872050 — PARAMAX CHOLESTEROL REAGENT
- K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
- K870158 — STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
- K870406 — SMI DIGITRON
- K870353 — IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
- K870354 — IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)
- K864272 — THROMBOPLASTIN.FS
- K864273 — THROMBOPLASTIN.C
- K864274 — THROMBOPLASTIN.R
- K863887 — SMI MULTIPETTOR(TM)
- K863594 — ACTIN FSL ACTIVATED PTT REAGENT
- K863489 — PARAMAX ELECTROLYTE CALIBRATOR
- K862428 — STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
- K862818 — STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
- K862440 — PARAMAX LIPASE REAGENT
- K862067 — STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
- K860906 — STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III
- K860422 — STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
- K860355 — BOVINE CHEMISTRY CONTROL I.X AND II.X
- K855199 — PARAMAX COMPREHENSIVE CALIBRATOR
- K860141 — STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
- K860421 — STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
- K860140 — STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
- K854651 — PARAAMAX CHLORIDE DETERMINATION BY ISE
- K853986 — THROMBOPLASTIN-R REAGENT
- K853548 — STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
- K853547 — STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
- K853531 — ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
- K853461 — COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
- K853462 — COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
- K852285 — DADE BLOOD GAS AMPUL INJECTOR
- K850574 — DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
- K850575 — DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H
- K850570 — STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
- K844158 — STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
- K844289 — SERIES I/S INFECTIONS
- K842537 — VON WILLEBRAND FACTOR ANTIGEN SCREEN
- K842617 — VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT
- K843184 — STRATUS LIDOCAINE FLUOROMETRIC ENZYME
- K843183 — STRATUS CORTISOL FLUOROMETRIC ENZYME
- K843237 — STRATUS QUINIDINE FLUOROMETRIC ENZYME
- K842196 — STRATUS PRIMIDONE FLOROMETRIC ENZY
- K841886 — PARAMAX IRON REAGENT
- K841887 — PARAMAX IRON BLANK REAGENT
- K841439 — COMA TOXICOLOGY CONTROL
- K841364 — COAGULATION FACTOR V DEFICIENT SUBSTR
- K840010 — DADE HEMATOLOGY CALIBRATOR PLUS
- K841047 — PARAMAX CHLORIDE REAGENT
- K840769 — PARAMAX ALCOHOL REAGENT
- K840771 — ALCOHOL & AMMONIA CALIBRATOR I
- K840772 — ALCOHOL & AMMONIA CALIBRATOR II
- K840778 — LACTATE REAGENT
- K840779 — NEONATAL BILIRUBIN REAGENT
- K840781 — URIC ACID REAGENT
- K840782 — ALBUMIN REAGENT
- K840784 — PARAMAX MAGNESIUM REAGENT
- K845052 — PARAMAX TOTAL PROTEIN REAGENT TP
- K840777 — DIRECT BILIRUBIN REAGENT
- K840780 — TRIGLYCERIDES REAGENT
- K840785 — PARAMAX UREA NITROGEN REAGENT
- K840661 — PARAMAX ACID PHOSPHATASE REAGENT
- K840706 — ASPARTATE AMINOTRANSFERASE REAGENT
- K840770 — PARAMAX AMMONIA REAGENTT
- K840773 — CARBON DIOXIDE REAGENT
- K840774 — CARBON DIOXIDE CALIBRATOR I
- K840775 — CARBON DIOXIDE CALIBRATOR II
- K840776 — PARAMAX CHOLESTEROL REAGENT
- K840783 — CREATINE KINASE MB REAGENT
- K834209 — STRATUS THYROID UPTAKE FLUOROMETRIC
- K840705 — PARAMAX ALANINE AMINOTRANSFERASE
- K834210 — STRATUS TOTAL THYROXINE FLUOROMETRIC
- K834050 — PROTOPATH FACTOR IX ASSAY
- K834051 — PROTOPATH FACTOR VIII ASSAY
- K832965 — STRATUS THEOPHYLLINE ASSAY
- K833353 — ACLAIM-QAP IBM PERSONAL COMPUTER EDT
- K833005 — PARAMAX BILIRUBIN CALIBRATORS
- K833272 — THROMBOPLASTIN - FS
- K833003 — PARAMAX SALICYLATE REAGENT
- K832708 — PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS
- K833001 — PARAMAX & GLUTAMYTRANSFERASE REAGENT
- K833002 — PARAMAX PHOSPHORUS REAGENT
- K833004 — PARAMAX TOTAL BILIRUBIN REAGENT
- K832447 — STRATUS CARBAMAZEPINE FLUROMETRIC
- K832336 — STRATUS AMIKACIN FLUOROMETRIC
- K832445 — STRATUS GENTAMICIN FLUOROMETRIC ENZYM
- K832408 — STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
- K832003 — AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
- K831480 — PARAMAX ALKALINE PHOSPHATASE REAGENT-
- K831537 — PARAMAX CREATINE KINASE REAGENT
- K831536 — PARAMAX AMALINE REAGENT
- K831140 — DADE HEMATOLOGY CALIBRATOR
- K831297 — PROTOTRO/PROTEOLYTIC ENZYME CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.