K-number	K150063
Device name	One Step hCG Pregnancy Test
Applicant	Coretests, Inc.
Product code	LCX
Device class	Class II
Decision date	Oct 2, 2015
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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One Step hCG Pregnancy Test

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