Medical Device Manufacturer · US , Mchenry , IL

Ortho Diagnostics, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1977

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ortho Diagnostics, Inc. Hematology ✕

11 devices

1-11 of 11

Cleared Mar 05, 1980

ORTHO ANTISERA CONTROL

Hematology · 22d

Cleared Oct 11, 1979

ORTHO ANTIBODY ENHANCEMENT SOLUTION

Hematology · 30d

Cleared Oct 17, 1978

NORMAL HEMATOLOGY CONTROL UNASSAYED

Hematology · 33d

Cleared Oct 17, 1978

ABNORMAL HEMATOLOGY CONTROL UNASSAYED

Hematology · 33d

Cleared Sep 14, 1978

ORTHO LOW IONIC SOLUTION

Hematology · 29d

Cleared Aug 10, 1978

PLASMA COAGULATION CONT., ABNORMAL

Hematology · 38d

Cleared Jan 31, 1978

ANTITHROMBIN III ASSAY

Hematology · 32d

Cleared Nov 08, 1977

LEWIS BLOOD GROUP SUBSTANCE

Hematology · 95d

Cleared Nov 08, 1977

P1 BLOOD GROUP SUBSTANCE

Hematology · 95d

Cleared Nov 07, 1977

REAGENT CONFIDENCE SERA

Hematology · 41d

Cleared Feb 07, 1977

MICROSAMPLE BLOOD COLLECTION DEVICE

Hematology · 75d