Clearance Summary
Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip received FDA 510(k) clearance under submission number K251697, sponsored by ACON Laboratories, Inc.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-11-26.
- Submission: K251697
- Applicant / Sponsor: ACON Laboratories, Inc.
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.3740
- Decision date: 2025-11-26
Classification & Regulation
This clearance is catalogued under FDA product code GTY and 21 CFR 866.3740, within the Microbiology review panel as a Class I device.