Medical Device Manufacturer · US , Mchenry , IL

American Dade - FDA 510(k) Cleared Devices

149 submissions · 149 cleared · Since 1980

149

Total

149

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Dade Hematology ✕

46 devices

1-12 of 46

Cleared Aug 06, 1987

DATA-FI DIMERTEST LATEX ASSAY

Hematology · 59d

Cleared Jul 06, 1987

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET

Hematology · 18d

Cleared Feb 10, 1987

IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)

Hematology · 12d

Cleared Feb 10, 1987

IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)

Hematology · 12d

Cleared Nov 13, 1986

THROMBOPLASTIN.FS

Hematology · 15d

Cleared Nov 13, 1986

THROMBOPLASTIN.C

Hematology · 15d

Cleared Nov 13, 1986

THROMBOPLASTIN.R

Hematology · 15d

Cleared Oct 17, 1986

ACTIN FSL ACTIVATED PTT REAGENT

Hematology · 32d

Cleared Nov 12, 1985

THROMBOPLASTIN-R REAGENT

Hematology · 46d

Cleared Aug 29, 1985

COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA

Hematology · 10d

Cleared Aug 29, 1985

COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA

Hematology · 10d

Cleared Oct 01, 1984

VON WILLEBRAND FACTOR ANTIGEN SCREEN

Hematology · 95d

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