Medical Device Manufacturer · US , Mchenry , IL

Organon Teknika Corp. - FDA 510(k) Cleared Devices

130 submissions · 129 cleared · Since 1980

130

Total

129

Cleared

0

Denied

FDA 510(k) Regulatory Record - Organon Teknika Corp. Hematology ✕

30 devices

1-12 of 30

Cleared Jun 07, 2000

Hematology · 113d

Cleared Jun 01, 1999

COAG-A-MATE MAX

Hematology · 61d

Cleared Apr 16, 1998

Hematology · 115d

Cleared Feb 24, 1998

MDA SIMPLASTIN HTF

Hematology · 81d

Cleared Mar 18, 1997

THROMBONOSTIKA F1.2

Hematology · 99d

Cleared Mar 18, 1997

MDA HEPARIN ANTI-X ASSAY

Hematology · 89d

Cleared Jan 22, 1997

COAG-A-MATE MTX

Hematology · 184d

Cleared Oct 06, 1995

MDA SIMPLASTIN LS

Hematology · 121d

Cleared Sep 20, 1994

Hematology · 48d

Cleared Apr 21, 1994

FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM

Hematology · 569d

Cleared Jan 27, 1994

MDA PROTEIN ASSAY

Hematology · 447d

Cleared Apr 20, 1993

VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA

Hematology · 61d