Name: Predicase
Price: 199 USD

K-number	K970894
Device name	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	DHA
Device class	Class II
Decision date	Apr 14, 1997
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)

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