K-number	K870627
Device name	AFFINITY (TM) HCG IMMUNIT (TM)
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	JHI
Device class	Class II
Decision date	May 28, 1987
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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AFFINITY (TM) HCG IMMUNIT (TM)

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