510(k) K063684
K063684 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "COBAS LITHIUM". The FDA issued a decision of Substantially Equivalent on March 21, 2008. The device falls under product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2008
- Date Received
- December 12, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Porphyrin, Spectrophotometry, Lithium
- Device Class
- Class II
- Regulation Number
- 862.3560
- Review Panel
- TX
- Submission Type