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Access Bio Incorporate
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CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST is an FDA 510(k)-cleared medical device (K031048) manufactured by Access Bio Incorporate. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2003. Regulation: 8.