Name: Predicase
Price: 199 USD

K-number	K964720
Device name	VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	CGJ
Device class	Class I
Decision date	Feb 4, 1997
Decision	Substantially Equivalent
Regulation	862.1300

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Source

View the full FDA submission: accessdata.fda.gov

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

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