Clearance Summary
cobas HbA1c Test, cobas b 101 system received FDA 510(k) clearance under submission number K163633, sponsored by Roche Diagnostics Operations. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2017-07-28.
- Submission: K163633
- Applicant / Sponsor: Roche Diagnostics Operations
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2017-07-28
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.