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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K252932
Device Name Fast PCR Mini Respiratory Panel
Applicant
Autonomous Medical Devices Incorporated
3511 W. Sunflower Ave.
Santa Ana,  CA  92704
Applicant Contact Aiying Sun
Correspondent
Autonomous Medical Devices Incorporated
3511 W. Sunflower Ave.
Santa Ana,  CA  92704
Correspondent Contact Aiying Sun
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Codes
OCC   OOI   OZE   PMN  
Date Received09/15/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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