Medical Device Manufacturer · US , North Brunswick , NJ

Access Bio Incorporate - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2003

Recent clearances: CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN, CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY, CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Access Bio Incorporate Chemistry ✕

4 devices

1-4 of 4

Cleared Nov 29, 2005

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN

Chemistry · 134d

Cleared Sep 05, 2003

CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

Chemistry · 52d

Cleared Jun 16, 2003

CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO...

Chemistry · 75d

Cleared Jun 13, 2003

CARESTART HCG ONE-STEP PREGNANCY TEST

Chemistry · 72d