Clearance Summary
BBL DIRECTIGEN TEST KIT received FDA 510(k) clearance under submission number K812808, sponsored by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1981-12-30.
- Submission: K812808
- Applicant / Sponsor: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.3740
- Decision date: 1981-12-30
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.