Name: Predicase
Price: 199 USD

K-number	K970643
Device name	VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	CHP
Device class	Class I
Decision date	Mar 18, 1997
Decision	Substantially Equivalent
Regulation	862.1260

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)

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