Name: Predicase
Price: 199 USD

K-number	K031031
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	MMI
Device class	Class II
Decision date	Sep 29, 2003
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

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