VITROS Immunodiagnostic Products hs Troponin I Reagent Pack— 510(k) K252393

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K252393 for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack, Substantially Equivalent on 2025-10-29. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2025-07-31
Decision date: 2025-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.