Clearance Summary
Healgen Strep A Rapid Test Strip (Throat Swab) received FDA 510(k) clearance under submission number K212623, sponsored by Healgen Scientific,, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2022-03-16.
- Submission: K212623
- Applicant / Sponsor: Healgen Scientific,, LLC
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.3740
- Decision date: 2022-03-16
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.