Name: Predicase
Price: 199 USD

K-number	K060678
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	LOL
Device class	Class II
Decision date	Sep 14, 2006
Decision	Substantially Equivalent
Regulation	866.3310

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS

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