Name: Predicase
Price: 199 USD

K-number	K964982
Device name	VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	CEP
Device class	Class I
Decision date	Feb 20, 1997
Decision	Substantially Equivalent
Regulation	862.1485

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)

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