Medical Device Manufacturer · US , Augusta , GA

Medical Diagnostic Technologies, Inc. - FDA 510(k) Cleared Devices

57 submissions · 57 cleared · Since 1985

57

Total

57

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medical Diagnostic Technologies, Inc. Hematology ✕

32 devices

1-12 of 32

Cleared Aug 12, 1997

SPECTROLYSE HEPARIN (ANTI-IIA)

Hematology · 62d

Cleared Nov 18, 1996

CHROMOLIZE PAI-1 KIT

Hematology · 98d

Cleared Aug 14, 1996

SPECTROLYSE ANTITHROMBIN III (ANTI-XA)

Hematology · 163d

Cleared Jul 31, 1996

CHROMOLIZE TPA ASSAY KIT

Hematology · 35d

Cleared Jun 05, 1996

TINTELIZE PAI-1 KIT

Hematology · 126d

Cleared May 24, 1996

LA POSITIVE CONTROL PLASMA

Hematology · 45d

Cleared Apr 03, 1996

VENOM TIEM REAGENT

Hematology · 146d

Cleared Feb 29, 1996

BIOCLOT PROTEIN S

Hematology · 76d

Cleared Dec 06, 1993

APTT-ES REAGENT

Hematology · 90d

Cleared Apr 17, 1992

RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA

Hematology · 46d

Cleared Mar 19, 1991

PLATELET AGGREGATION REAGENTS

Hematology · 56d

Cleared Dec 28, 1990

COAGULATION REFERENCE PLASMA, NORMAL

Hematology · 38d