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

1-12 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