Access Bio Incorporate - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Access Bio Incorporate Chemistry ✕
4 devices
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