Name: Predicase
Price: 199 USD

K-number	K031048
Device name	CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
Applicant	Access Bio Incorporate
Product code	JHI
Device class	Class II
Decision date	Jun 16, 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 COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST

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