FDA 510(k)

Fast PCR Mini Respiratory Panel

K-Nummer: K252932 · 2026-06-12

AntragstellerAutonomous Medical Devices Incorporated

Entscheidungsdatum2026-06-12

ProduktcodeQOF

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

Fast PCR Mini Respiratory Panel is the device name listed in this FDA 510(k) record. The listed applicant is Autonomous Medical Devices Incorporated. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252932. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Fast PCR Mini Respiratory Panel?

Fast PCR Mini Respiratory Panel is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Autonomous Medical Devices Incorporated. The 510(k) number is K252932.

When did Fast PCR Mini Respiratory Panel receive FDA 510(k) clearance?

Fast PCR Mini Respiratory Panel received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252932.

Who is the listed applicant for Fast PCR Mini Respiratory Panel?

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

What is the FDA product code for Fast PCR Mini Respiratory Panel?

The FDA product code for Fast PCR Mini Respiratory Panel is QOF.

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Verwandte Geräte (Code: QOF)

K261336Xpert Respiratory PanelCepheid K263054BIOFIRE Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics K261837FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics Limited K251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLC

Offizielle Quelle

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