Clearance Summary
BACTEC MYCO/F LYTIC CULTURE VIALS received FDA 510(k) clearance under submission number K970333, sponsored by Becton Dickinson Microbiology Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1998-01-28.
- Submission: K970333
- Applicant / Sponsor: Becton Dickinson Microbiology Systems
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.2560
- Decision date: 1998-01-28
Classification & Regulation
This clearance is catalogued under FDA product code MDB and 21 CFR 866.2560, within the Microbiology review panel as a Class I device.