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American Dade

149 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY (K873051)American Dade1987-10-20
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K873171)American Dade1987-09-29
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (K873052)American Dade1987-09-14
PARAMAX URINE/CSF CALIBRATOR (K872789)American Dade1987-09-02
DATA-FI DIMERTEST LATEX ASSAY (K872195)American Dade1987-08-06
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (K872196)American Dade1987-07-31
STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (K871972)American Dade1987-07-21
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (K871977)American Dade1987-07-09
PARAMAX CHOLESTEROL REAGENT (K872050)American Dade1987-07-07
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (K872360)American Dade1987-07-06
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. (K870158)American Dade1987-03-19
SMI DIGITRON (K870406)American Dade1987-02-25
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN) (K870353)American Dade1987-02-10
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) (K870354)American Dade1987-02-10
THROMBOPLASTIN.R (K864274)American Dade1986-11-13
THROMBOPLASTIN.C (K864273)American Dade1986-11-13
THROMBOPLASTIN.FS (K864272)American Dade1986-11-13
SMI MULTIPETTOR(TM) (K863887)American Dade1986-11-05
ACTIN FSL ACTIVATED PTT REAGENT (K863594)American Dade1986-10-17
PARAMAX ELECTROLYTE CALIBRATOR (K863489)American Dade1986-09-29
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY (K862818)American Dade1986-08-19
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY (K862428)American Dade1986-08-19
PARAMAX LIPASE REAGENT (K862440)American Dade1986-08-04
STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY (K862067)American Dade1986-06-16
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III (K860906)American Dade1986-05-29
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY (K860422)American Dade1986-04-11
BOVINE CHEMISTRY CONTROL I.X AND II.X (K860355)American Dade1986-03-17
PARAMAX COMPREHENSIVE CALIBRATOR (K855199)American Dade1986-02-19
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. (K860141)American Dade1986-02-11
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY (K860421)American Dade1986-02-11
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. (K860140)American Dade1986-02-06
PARAAMAX CHLORIDE DETERMINATION BY ISE (K854651)American Dade1985-12-13
THROMBOPLASTIN-R REAGENT (K853986)American Dade1985-11-12
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS (K853548)American Dade1985-09-18
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I (K853547)American Dade1985-09-16
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER (K853531)American Dade1985-09-04
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA (K853462)American Dade1985-08-29
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA (K853461)American Dade1985-08-29
DADE BLOOD GAS AMPUL INJECTOR (K852285)American Dade1985-07-09
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO (K850574)American Dade1985-04-12
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H (K850575)American Dade1985-04-10
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY (K850570)American Dade1985-04-02
SERIES I/S INFECTIONS (K844289)American Dade1984-11-19
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY (K844158)American Dade1984-11-19
VON WILLEBRAND FACTOR ANTIGEN SCREEN (K842537)American Dade1984-10-01
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT (K842617)American Dade1984-10-01
STRATUS LIDOCAINE FLUOROMETRIC ENZYME (K843184)American Dade1984-09-26
STRATUS CORTISOL FLUOROMETRIC ENZYME (K843183)American Dade1984-09-17
STRATUS QUINIDINE FLUOROMETRIC ENZYME (K843237)American Dade1984-09-12
STRATUS PRIMIDONE FLOROMETRIC ENZY (K842196)American Dade1984-07-11
PARAMAX IRON BLANK REAGENT (K841887)American Dade1984-06-22
PARAMAX IRON REAGENT (K841886)American Dade1984-06-22
COMA TOXICOLOGY CONTROL (K841439)American Dade1984-05-16
COAGULATION FACTOR V DEFICIENT SUBSTR (K841364)American Dade1984-04-25
PARAMAX CHLORIDE REAGENT (K841047)American Dade1984-04-19
DADE HEMATOLOGY CALIBRATOR PLUS (K840010)American Dade1984-04-19
ALCOHOL & AMMONIA CALIBRATOR II (K840772)American Dade1984-04-13
LACTATE REAGENT (K840778)American Dade1984-04-13
ALCOHOL & AMMONIA CALIBRATOR I (K840771)American Dade1984-04-13
URIC ACID REAGENT (K840781)American Dade1984-04-13
PARAMAX TOTAL PROTEIN REAGENT TP (K845052)American Dade1984-04-13
ALBUMIN REAGENT (K840782)American Dade1984-04-13
NEONATAL BILIRUBIN REAGENT (K840779)American Dade1984-04-13
PARAMAX ALCOHOL REAGENT (K840769)American Dade1984-04-13
PARAMAX MAGNESIUM REAGENT (K840784)American Dade1984-04-13
TRIGLYCERIDES REAGENT (K840780)American Dade1984-04-05
DIRECT BILIRUBIN REAGENT (K840777)American Dade1984-04-05
PARAMAX UREA NITROGEN REAGENT (K840785)American Dade1984-04-05
CARBON DIOXIDE CALIBRATOR I (K840774)American Dade1984-04-04
PARAMAX CHOLESTEROL REAGENT (K840776)American Dade1984-04-04
ASPARTATE AMINOTRANSFERASE REAGENT (K840706)American Dade1984-04-04
CARBON DIOXIDE CALIBRATOR II (K840775)American Dade1984-04-04
PARAMAX AMMONIA REAGENTT (K840770)American Dade1984-04-04
PARAMAX ACID PHOSPHATASE REAGENT (K840661)American Dade1984-04-04
CARBON DIOXIDE REAGENT (K840773)American Dade1984-04-04
CREATINE KINASE MB REAGENT (K840783)American Dade1984-04-04
PARAMAX ALANINE AMINOTRANSFERASE (K840705)American Dade1984-03-09
STRATUS THYROID UPTAKE FLUOROMETRIC (K834209)American Dade1984-03-09
STRATUS TOTAL THYROXINE FLUOROMETRIC (K834210)American Dade1984-03-05
PROTOPATH FACTOR VIII ASSAY (K834051)American Dade1984-02-04
PROTOPATH FACTOR IX ASSAY (K834050)American Dade1984-02-04
STRATUS THEOPHYLLINE ASSAY (K832965)American Dade1983-12-30
ACLAIM-QAP IBM PERSONAL COMPUTER EDT (K833353)American Dade1983-12-22
PARAMAX BILIRUBIN CALIBRATORS (K833005)American Dade1983-11-14
THROMBOPLASTIN - FS (K833272)American Dade1983-11-03
PARAMAX SALICYLATE REAGENT (K833003)American Dade1983-10-28
PARAMAX PHOSPHORUS REAGENT (K833002)American Dade1983-10-14
PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS (K832708)American Dade1983-10-14
PARAMAX & GLUTAMYTRANSFERASE REAGENT (K833001)American Dade1983-10-14
PARAMAX TOTAL BILIRUBIN REAGENT (K833004)American Dade1983-10-14
STRATUS CARBAMAZEPINE FLUROMETRIC (K832447)American Dade1983-09-12
STRATUS GENTAMICIN FLUOROMETRIC ENZYM (K832445)American Dade1983-08-31
STRATUS AMIKACIN FLUOROMETRIC (K832336)American Dade1983-08-31
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (K832408)American Dade1983-08-26
AQUEOUS BLOOD GAS CONTROL LEVEL I,II & (K832003)American Dade1983-08-10
PARAMAX ALKALINE PHOSPHATASE REAGENT- (K831480)American Dade1983-06-22
PARAMAX CREATINE KINASE REAGENT (K831537)American Dade1983-06-22
PARAMAX AMALINE REAGENT (K831536)American Dade1983-06-17
DADE HEMATOLOGY CALIBRATOR (K831140)American Dade1983-06-08
PROTOTRO/PROTEOLYTIC ENZYME CONTROL (K831297)American Dade1983-06-08
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