FDA 510(k), K083716, FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)

FDA 510(k), K083716, FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)

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510(K) Number: K083716
Device Name: FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
Manufacturer:
Device Classification Name: Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation Number: 862.1155
Classification Product Code: LCX
Date Received: 12/15/2008
Decision Date: 06/08/2009
Regulation Medical Specialty: Clinical Chemistry
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