510(k) K200811
K200811 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "cobas u 701 microscopy analyzer". The FDA issued a decision of Substantially Equivalent on November 6, 2020. The device falls under product code LKM (Counter, Urine Particle), a Class II device regulated under 21 CFR 864.5200. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2020
- Date Received
- March 27, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Urine Particle
- Device Class
- Class II
- Regulation Number
- 864.5200
- Review Panel
- HE
- Submission Type