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FDA 510(k)

Fast PCR Mini Respiratory Panel

K-Number: K252932 · 2026-06-12

ApplicantAutonomous Medical Devices Incorporated
Decision Date2026-06-12
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07267624EARLY Antibiotics aDAptation in Severe Pneumonia(The EARLY ADAPT Study)NOT_YET_RECRUITINGNCT07631377The LalelaLung Study: Digital Stethoscope Clinical EvaluationNOT_YET_RECRUITING

Related Devices (Code: QOF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.K251742VELO Respiratory TestLex Diagnostics LimitedK251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLCK252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Diasorin Molecular, LLCK250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbHK243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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