Name: Predicase
Price: 199 USD

K-number	K062838
Device name	VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
Applicant	Ortho-Clinical Diagnostics
Product code	MMI
Device class	Class II
Decision date	Dec 19, 2006
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303

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