Name: Predicase
Price: 199 USD

K-number	K063720
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
Applicant	Ortho-Clinical Diagnostics
Product code	DHA
Device class	Class II
Decision date	Apr 9, 2007
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

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