Fast PCR Mini Respiratory Panel
FDA 510(k) clearance K252932 · decided 2026-06-12
Clearance details
- K-number
- K252932
- Device name
- Fast PCR Mini Respiratory Panel
- Applicant
- Autonomous Medical Devices Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2025-09-15
- Decision date
- 2026-06-12
- Days to decision
- 270 days
- Clearance type
- Dual Track
- Product code
- QOF
- Device class
- 2
- Regulation number
- 866.3981
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.