K-number	K031052
Device name	CARESTART HCG ONE-STEP PREGNANCY TEST
Applicant	Access Bio Incorporate
Product code	DHA
Device class	Class II
Decision date	Jun 13, 2003
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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CARESTART HCG ONE-STEP PREGNANCY TEST

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