510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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American Dade

Mchenry, IL, US

American Dade appears in FDA device records in Mchenry, IL. FDA records list 149 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
149
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 149

FDA records hold 149 510(k) clearances for American Dade between 1980 and 1987. The busiest year on record is 1984, with 39. The most recent is 1987, with 14.

Clearances by year, as a table
510(k) clearance decisions for American Dade, by decision year
YearClearances
19804
198124
198214
198326
198439
198511
198617
198714
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYCGJSubstantially Equivalent
K873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYJHXSubstantially Equivalent
K873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYCEPSubstantially Equivalent
K872789PARAMAX URINE/CSF CALIBRATORJIXSubstantially Equivalent
K872195DATA-FI DIMERTEST LATEX ASSAYDAPSubstantially Equivalent
K872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & IIIJJSSubstantially Equivalent
K871972STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAYDGESubstantially Equivalent
K871977DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATORJJYSubstantially Equivalent
K872050PARAMAX CHOLESTEROL REAGENTLBSSubstantially Equivalent
K872360DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SETGHHSubstantially Equivalent
K870158STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.CECSubstantially Equivalent
K870406SMI DIGITRONJQWSubstantially Equivalent
K870354IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)GGPSubstantially Equivalent
K870353IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)GGPSubstantially Equivalent
K864274THROMBOPLASTIN.RGJSSubstantially Equivalent
K864273THROMBOPLASTIN.CGJSSubstantially Equivalent
K864272THROMBOPLASTIN.FSGJSSubstantially Equivalent
K863887SMI MULTIPETTOR(TM)JQWSubstantially Equivalent
K863594ACTIN FSL ACTIVATED PTT REAGENTGGWSubstantially Equivalent
K863489PARAMAX ELECTROLYTE CALIBRATORJIXSubstantially Equivalent
K862818STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAYJJESubstantially Equivalent
K862428STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAYJLWSubstantially Equivalent
K862440PARAMAX LIPASE REAGENTCETSubstantially Equivalent
K862067STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAYLFMSubstantially Equivalent
K860906STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, IIIJJYSubstantially Equivalent
K860422STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAYKHQSubstantially Equivalent
K860355BOVINE CHEMISTRY CONTROL I.X AND II.XJJYSubstantially Equivalent
K855199PARAMAX COMPREHENSIVE CALIBRATORJIXSubstantially Equivalent
K860421STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAYCDXSubstantially Equivalent
K860141STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.LARSubstantially Equivalent
K860140STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.LANSubstantially Equivalent
K854651PARAAMAX CHLORIDE DETERMINATION BY ISECGJSubstantially Equivalent
K853986THROMBOPLASTIN-R REAGENTJPASubstantially Equivalent
K853548STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASSLCMSubstantially Equivalent
K853547STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME ILANSubstantially Equivalent
K853531ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZERCEMSubstantially Equivalent
K853462COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMAGGPSubstantially Equivalent
K853461COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMAGGPSubstantially Equivalent
K852285DADE BLOOD GAS AMPUL INJECTORJQWSubstantially Equivalent
K850574DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY COJJYSubstantially Equivalent
K850575DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II HJJYSubstantially Equivalent
K850570STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAYJHISubstantially Equivalent
K844289SERIES I/S INFECTIONSKTNSubstantially Equivalent
K844158STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAYDBFSubstantially Equivalent
K842617VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANTGGPSubstantially Equivalent
K842537VON WILLEBRAND FACTOR ANTIGEN SCREENICFSubstantially Equivalent
K843184STRATUS LIDOCAINE FLUOROMETRIC ENZYMEKLRSubstantially Equivalent
K843183STRATUS CORTISOL FLUOROMETRIC ENZYMECGRSubstantially Equivalent
K843237STRATUS QUINIDINE FLUOROMETRIC ENZYMELBZSubstantially Equivalent
K842196STRATUS PRIMIDONE FLOROMETRIC ENZYLFTSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of , FDA export datePage updated Source: openFDA, public domain