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 the device name listed in this FDA 510(k) record. The listed applicant is Phc Corporation. It received FDA 510(k) clearance on 2024-03-20 under 510(k) 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. The listed applicant is Phc Corporation. The 510(k) number is K231974.

When did PATHFAST®hs-cTnI-II receive FDA 510(k) clearance?

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

Who is the listed applicant for PATHFAST®hs-cTnI-II?

The FDA 510(k) record lists Phc Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: MMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.

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.