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

30 devices

26-30 of 30

Cleared May 18, 1988

COAG-A-MATE(R) XM

Hematology · 54d

Cleared May 02, 1988

VERIFY(R) REFERENCE PLASMA

Hematology · 33d

Cleared Feb 09, 1988

Hematology · 29d

Cleared Mar 17, 1987

COAG-A-MATE(R) XC

Hematology · 7d

Cleared Dec 04, 1986

SIMPLASTIN EXCEL

Hematology · 35d