Clearance Summary
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit received FDA 510(k) clearance under submission number K190433, sponsored by Roche Molecular Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2019-05-22.
- Submission: K190433
- Applicant / Sponsor: Roche Molecular Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3393
- Decision date: 2019-05-22
Classification & Regulation
This clearance is catalogued under FDA product code QEP and 21 CFR 866.3393, within the Microbiology review panel as a Class II device.