Name: Predicase
Price: 199 USD

K-number	K060940
Device name	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	JIX
Device class	Class II
Decision date	Apr 24, 2006
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III

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