Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel— 510(k) K241806

Name: FDA 510(k) clearance K241806
Creator: U.S. Food and Drug Administration
Published: 2025-01-08

Substantially Equivalent

Life Technologies Corporation

FDA 510(k) clearance K241806 for Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel, Substantially Equivalent on 2025-01-08. Applicant: Life Technologies Corporation. Device class: 2.

Clearance details

Applicant: Life Technologies Corporation
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2024-06-21
Decision date: 2025-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton,, CA, US

Download summary PDF View on FDA.gov ↗

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K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT2013-03-08
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Data sourced from openFDA. This site is unofficial and independent of the FDA.