Status COVID-19/Flu A&B— 510(k) K251538
Substantially EquivalentPrinceton BioMeditech Corp.
FDA 510(k) clearance K251538 for Status COVID-19/Flu A&B, Substantially Equivalent on 2025-11-14. Applicant: Princeton BioMeditech Corp.. Device class: 2.
Clearance details
- Applicant
- Princeton BioMeditech Corp.
- Product code
- Code SCA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3987
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Monmouth Junction, NJ, US
Recent devices under product code SCA
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- K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
- K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
More clearances from Princeton BioMeditech Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.