Name: Predicase
Price: 199 USD

K-number	K964721
Device name	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	KLI
Device class	Class II
Decision date	Dec 18, 1996
Decision	Substantially Equivalent
Regulation	862.1700

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)

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