American Dade

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
149
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYOctober 20, 1987
K873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYSeptember 29, 1987
K873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYSeptember 14, 1987
K872789PARAMAX URINE/CSF CALIBRATORSeptember 2, 1987
K872195DATA-FI DIMERTEST LATEX ASSAYAugust 6, 1987
K872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & IIIJuly 31, 1987
K871972STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAYJuly 21, 1987
K871977DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATORJuly 9, 1987
K872050PARAMAX CHOLESTEROL REAGENTJuly 7, 1987
K872360DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SETJuly 6, 1987
K870158STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.March 19, 1987
K870406SMI DIGITRONFebruary 25, 1987
K870354IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)February 10, 1987
K870353IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)February 10, 1987
K864273THROMBOPLASTIN.CNovember 13, 1986
K864274THROMBOPLASTIN.RNovember 13, 1986
K864272THROMBOPLASTIN.FSNovember 13, 1986
K863887SMI MULTIPETTOR(TM)November 5, 1986
K863594ACTIN FSL ACTIVATED PTT REAGENTOctober 17, 1986
K863489PARAMAX ELECTROLYTE CALIBRATORSeptember 29, 1986