Name: Predicase
Price: 199 USD

K-number	K965142
Device name	VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	CEC
Device class	Class II
Decision date	Mar 18, 1997
Decision	Substantially Equivalent
Regulation	862.1695

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View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)

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