FDA 510(k)

Panther Fusion GI Bacterial Assay

K号: K251868 · 2025-09-25

决定日期2025-09-25

产品代码PCH

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决定实质等同

器械摘要

Panther Fusion GI Bacterial Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251868. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Panther Fusion GI Bacterial Assay?

Panther Fusion GI Bacterial Assay is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Hologic. The 510(k) number is K251868.

When did Panther Fusion GI Bacterial Assay receive FDA 510(k) clearance?

Panther Fusion GI Bacterial Assay received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251868.

Who is the listed applicant for Panther Fusion GI Bacterial Assay?

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

What is the FDA product code for Panther Fusion GI Bacterial Assay?

The FDA product code for Panther Fusion GI Bacterial Assay is PCH.

列明Hologic为申报人的其他记录

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