Status™ COVID-19/Flu A&B
FDA 510(k) clearance K251538 · decided 2025-11-14
Clearance details
- K-number
- K251538
- Device name
- Status™ COVID-19/Flu A&B
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-19
- Decision date
- 2025-11-14
- Days to decision
- 179 days
- Clearance type
- Dual Track
- Product code
- SCA
- Device class
- 2
- Regulation number
- 866.3987
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Monmouth Junction, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.