K-number	K132834
Device name	FASTEP S10 HCG SERUM/URINE COMBO TEST
Applicant	Polymed Therapeutics, Inc.
Product code	JHI
Device class	Class II
Decision date	Jan 9, 2014
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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FASTEP S10 HCG SERUM/URINE COMBO TEST

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