Name: Predicase
Price: 199 USD

K-number	K964310
Device name	VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	CDP
Device class	Class II
Decision date	Nov 27, 1996
Decision	Substantially Equivalent
Regulation	862.1710

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)

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