Name: Predicase
Price: 199 USD

K-number	K974425
Device name	BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
Applicant	Princeton BioMeditech Corp.
Product code	DHA
Device class	Class II
Decision date	Dec 24, 1997
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST

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