Name: Predicase
Price: 199 USD

K-number	K964558
Device name	VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	JLW
Device class	Class II
Decision date	Dec 16, 1996
Decision	Substantially Equivalent
Regulation	862.1690

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

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