Medical Device Manufacturer · US , Eatontown , NJ

Biotech Atlantic, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1994

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Nov 21, 2003

UNIMARK HOME PREGNANCY TEST DEVICE

Chemistry · 57d

Cleared Oct 10, 2001

UNIMARK HCG COMBO PREGNANCY TEST

Chemistry · 15d

Cleared Apr 01, 1996

UNIMARK MIDSTREAM PREGNANCY TEST STICK

Chemistry · 76d

Cleared Jun 02, 1994

UNISTEP HCG PREGNANCY TEST STRIP

Chemistry · 86d