Name: Predicase
Price: 199 USD

K-number	K042643
Device name	VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	DCF
Device class	Class II
Decision date	Nov 18, 2004
Decision	Substantially Equivalent
Regulation	866.5040

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II

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