K-number	K962888
Device name	AFFIRM ONE-STEP HOME PREGNANCY TEST
Applicant	Athena Medical Corp.
Product code	LCX
Device class	Class II
Decision date	Sep 23, 1996
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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AFFIRM ONE-STEP HOME PREGNANCY TEST

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