Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay— 510(k) K222736

Name: FDA 510(k) clearance K222736
Creator: U.S. Food and Drug Administration
Published: 2023-05-16

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K222736 for Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, Substantially Equivalent on 2023-05-16. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2022-09-09
Decision date: 2023-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

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K261837 — FINDER Flu A&B/SARS-CoV-2 Test2026-09-11
K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K252269 — FINDER Flu A&B/SARS-CoV-2 Test2026-03-30
K251742 — VELO Respiratory Test2026-02-13
K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23

More clearances from Hologic, Inc.

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K253634 — CoolSeal Generator® (CSL-200-90)2026-06-17
K251993 — Panther Fusion GI Expanded Bacterial Assay2025-09-25
K243341 — Genius AI Detection 2.02025-07-31

Recalls naming K222736

K-number listed on FDA's recall record

Z-0694-2025 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400Class II·Ongoing·Hologic, Inc.·20241108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K222736.

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