K-number	K990373
Device name	FACT PLUS ONE STEP PREGNANCY TEST
Applicant	Abbott Laboratories
Product code	LCX
Device class	Class II
Decision date	Feb 22, 1999
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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FACT PLUS ONE STEP PREGNANCY TEST

Everything you need for a 510(k) submission. Nothing you don't.