Panther Fusion GI Bacterial Assay— 510(k) K251868

Substantially Equivalent

Hologic

FDA 510(k) clearance K251868 for Panther Fusion GI Bacterial Assay, Substantially Equivalent on 2025-09-25. Applicant: Hologic. Device class: 2.

Clearance details

Applicant: Hologic
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2025-06-18
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PCH

K253722 — LIAISON PLEX Gastrointestinal Flex Assay2026-05-19
K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2026-03-09
K251721 — Xpert GI Panel2026-01-16
K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2025-10-22
K251993 — Panther Fusion GI Expanded Bacterial Assay2025-09-25

More clearances from Hologic

K161575 — Affirm Lateral Arm Upright Biopsy Accessory2016-08-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.