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FDA 510(k)

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

K-Number: K252393 · 2025-10-29

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2025-10-29
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-10-29 under approval number K252393. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K252393.

When was VITROS Immunodiagnostic Products hs Troponin I Reagent Pack approved by the FDA?

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack received FDA 510(k) clearance on 2025-10-29, under approval number K252393.

What company makes VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is manufactured by Ortho-Clinical Diagnostics, Inc..

What is the FDA product code for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is MMI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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