Name: Predicase
Price: 199 USD

K-number	K252393
Device name	VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	MMI
Device class	Class II
Decision date	Oct 29, 2025
Decision	Substantially Equivalent
Regulation	862.1215

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

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