Medical Device Manufacturer · US , Mchenry , IL

Organon, Inc. - FDA 510(k) Cleared Devices

41 submissions · 41 cleared · Since 1977

41

Total

41

Cleared

0

Denied

FDA 510(k) Regulatory Record - Organon, Inc. Chemistry ✕

23 devices

1-23 of 23

Cleared Aug 24, 1984

DUOCLON COLOR-CEPT

Chemistry · 73d

Cleared Jun 05, 1984

OREIA II B-HCG PREGNANCY TEST KIT

Chemistry · 54d

Cleared May 22, 1984

ACCURATE BETA 30 PREGNANCY TEST KIT

Chemistry · 34d

Cleared Apr 04, 1984

Chemistry · 49d

Cleared Dec 08, 1983

OREIA II B-HCG, ENZYME INNUNOASSAY

Chemistry · 112d

Cleared Jan 07, 1983

BETA FFIRM TEST

Chemistry · 31d

Cleared Nov 06, 1981

Chemistry · 15d

Cleared Sep 01, 1981

Chemistry · 14d

Cleared Aug 31, 1981

Chemistry · 19d

Cleared Aug 03, 1981

OREIA II, B-HCG

Chemistry · 28d

Cleared Jul 27, 1981

Chemistry · 21d

Cleared Dec 19, 1980

Chemistry · 28d

Cleared Dec 10, 1980

OREIA-Q-TY, ENZYME IMMUNOASSAY

Chemistry · 41d

Cleared Oct 31, 1980

OREAI-Q-TU TEST

Chemistry · 22d

Cleared Oct 30, 1979

OREIA-TU THYROID UPTAKER RATIO ASSAY

Chemistry · 127d

Cleared Oct 01, 1979

QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)

Chemistry · 32d

Cleared Jun 15, 1979

PREGNOSTICON PREGNANCY TEST KIT

Chemistry · 60d

Cleared Oct 11, 1978

Chemistry · 30d

Cleared Apr 12, 1978

Chemistry · 48d

Cleared Feb 27, 1978

Chemistry · 14d

Cleared Nov 23, 1977

Chemistry · 20d

Cleared Sep 02, 1977

HYPRONOSTICON TM

Chemistry · 156d

Cleared Jun 15, 1977

TUBES, HYDROLYSIS, CALIBRATED

Chemistry · 76d