Name: Predicase
Price: 199 USD

K-number	K061588
Device name	VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	LPS
Device class	Class II
Decision date	Jul 21, 2006
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 REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS

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