PATHFAST®hs-cTnI-II— 510(k) K231974

Name: FDA 510(k) clearance K231974
Creator: U.S. Food and Drug Administration
Published: 2024-03-20

Substantially Equivalent

Phc Corporation

FDA 510(k) clearance K231974 for PATHFAST®hs-cTnI-II, Substantially Equivalent on 2024-03-20. Applicant: Phc Corporation. Device class: 2.

Clearance details

Applicant: Phc Corporation
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2023-07-03
Decision date: 2024-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code MMI

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K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System2026-06-11
K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack2025-10-29
K243483 — Access hsTnI2025-08-01
K242870 — Access hsTnI2025-06-16
K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System2025-01-03

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.