Name: Predicase
Price: 199 USD

K-number	K060480
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
Applicant	Ortho-Clinical Diagnostics
Product code	CGR
Device class	Class II
Decision date	Jul 3, 2006
Decision	Substantially Equivalent
Regulation	862.1205

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS

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