PATHFAST®hs-cTnI-II— 510(k) K231974

Substantially Equivalent

Phc Corporation

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

Clearance details

Applicant: Phc Corporation
Product code: Code MMI
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 ↗

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.