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. Immunology ✕

3 devices

1-3 of 3

Cleared Oct 23, 1980

ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE

Immunology · 17d

Cleared Dec 20, 1978

RUBINDEX*DIRECT SYSTEM

Immunology · 90d

Cleared Aug 31, 1978

DIGOXIN RIA (PEG) KIT

Immunology · 29d