510(k) K060108
K060108 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "COBAS INTEGRA CHLORIDE ELCTRODE GEN.2". The FDA issued a decision of Substantially Equivalent on February 16, 2006. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2006
- Date Received
- January 13, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion-Specific, Chloride
- Device Class
- Class II
- Regulation Number
- 862.1170
- Review Panel
- CH
- Submission Type