FINDER Flu A&B/SARS-CoV-2 Test
FDA 510(k) clearance K252269 · decided 2026-03-30
Clearance details
- K-number
- K252269
- Device name
- FINDER Flu A&B/SARS-CoV-2 Test
- Applicant
- Baebies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-21
- Decision date
- 2026-03-30
- Days to decision
- 252 days
- Clearance type
- Dual Track
- Product code
- QOF
- Device class
- 2
- Regulation number
- 866.3981
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.