CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY— 510(k) K032159

Substantially Equivalent

Access Bio Incorporate

FDA 510(k) clearance K032159 for CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY, Substantially Equivalent on 2003-09-05. Applicant: Access Bio Incorporate.

Clearance details

Applicant
Access Bio Incorporate
Product code
Code LCX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Brunswick, NJ, US
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