Name: Predicase
Price: 199 USD

K-number	K060770
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	LOL
Device class	Class II
Decision date	Sep 15, 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 IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS

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