Cleared Traditional

PATHFAST?hs-cTnI-II

K231974 · Phc Corporation · Chemistry

Mar 2024

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K231974 is an FDA 510(k) clearance for the PATHFAST?hs-cTnI-II, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Phc Corporation (Tokyo, JP). The FDA issued a Cleared decision on March 20, 2024, 261 days after receiving the submission on July 3, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K231974 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2023
Decision Date	March 20, 2024
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF