Name: Predicase
Price: 199 USD

K-number	K123930
Device name	VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	LPS
Device class	Class II
Decision date	May 15, 2013
Decision	Substantially Equivalent
Regulation	862.1377

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III

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