Clearance Summary
MB/BACT MYCROBACTERIA DETECTION SYSTEM received FDA 510(k) clearance under submission number K954468, sponsored by Organon Teknika Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1996-07-22.
- Submission: K954468
- Applicant / Sponsor: Organon Teknika Corp.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.2560
- Decision date: 1996-07-22
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.