K251697
- 510(k) number
- K251697
- Device name
- Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- Applicant
- ACON Laboratories, Inc. CA · US
- Product code
- GTY — Antigens, All Groups, Streptococcus Spp.
- Decision date
- 2025-11-26
- Date received
- 2025-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251697
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.