Fast PCR Mini Respiratory Panel— 510(k) K252932

Name: FDA 510(k) clearance K252932
Creator: U.S. Food and Drug Administration
Published: 2026-06-12

Substantially Equivalent

Autonomous Medical Devices Incorporated

FDA 510(k) clearance K252932 for Fast PCR Mini Respiratory Panel, Substantially Equivalent on 2026-06-12. Applicant: Autonomous Medical Devices Incorporated. Device class: 2.

Clearance details

Applicant: Autonomous Medical Devices Incorporated
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2025-09-15
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Santa Ana, 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
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
K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)2025-10-30

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