FDA 510(k)

PATHFAST®hs-cTnI-II

K-Number: K231974 · 2024-03-20

Decision Date2024-03-20

Product CodeMMI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PATHFAST®hs-cTnI-II is a medical device manufactured by Phc Corporation. It received FDA 510(k) clearance on 2024-03-20 under approval number K231974. 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 PATHFAST®hs-cTnI-II?

PATHFAST®hs-cTnI-II is a medical device that received FDA 510(k) clearance on 2024-03-20. It is manufactured by Phc Corporation. The 510(k) number is K231974.

When was PATHFAST®hs-cTnI-II approved by the FDA?

PATHFAST®hs-cTnI-II received FDA 510(k) clearance on 2024-03-20, under approval number K231974.

What company makes PATHFAST®hs-cTnI-II?

PATHFAST®hs-cTnI-II is manufactured by Phc Corporation.

What is the FDA product code for PATHFAST®hs-cTnI-II?

The FDA product code for PATHFAST®hs-cTnI-II is MMI.

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Official Source

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