Name: Predicase
Price: 199 USD

K-number	K063164
Device name	VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	LDJ
Device class	Class II
Decision date	Dec 28, 2006
Decision	Substantially Equivalent
Regulation	862.3870

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV

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