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. Chemistry ✕

8 devices

1-8 of 8

Cleared Sep 24, 1979

ORTHO TSH RIA KIT

Chemistry · 70d

Cleared Jun 28, 1979

MULTECON BLOOD GAS CONTROL

Chemistry · 62d

Cleared Apr 04, 1979

PREGNANCY, SENSIDEX TUBE TEST

Chemistry · 114d

Cleared Apr 04, 1979

SLIDE TEST FOR PREGNANCY, GRAVINDEX 90

Chemistry · 96d

Cleared Dec 04, 1978

ASSAY, CHROMOGENIC ANTITHROMBIN III

Chemistry · 28d

Cleared Sep 27, 1978

ORTHO*T-3 RIA (PEG) KIT

Chemistry · 30d

Cleared Sep 27, 1978

ORTHO*T-3 UPTAKE KIT

Chemistry · 30d

Cleared Sep 27, 1978

ORTHO*T-4 RIA (PEG) KIT

Chemistry · 30d