Medical Device Manufacturer · US , Walker , MI

Ortho Pharmaceutical Corp. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1979

Recent clearances: K-Y PERSONAL LUBRICANT, ADVANCE PREGNANCY TEST MODIFICATION, ADVANCE(R) PREGNANCY TEST

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ortho Pharmaceutical Corp. Chemistry ✕

3 devices

1-3 of 3

Cleared Feb 24, 1994

ADVANCE PREGNANCY TEST MODIFICATION

Chemistry · 160d

Cleared Dec 23, 1991

ADVANCE(R) PREGNANCY TEST

Chemistry · 46d

Cleared Mar 17, 1981

FACT* HOME PREGNANCY TEST

Chemistry · 14d