K063684 is an FDA 510(k) clearance for the COBAS LITHIUM. This device is classified as a Assay, Porphyrin, Spectrophotometry, Lithium (Class II - Special Controls, product code NDW).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 21, 2008, 465 days after receiving the submission on December 12, 2006.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3560.
| 510(k) Number | K063684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2006 |
| Decision Date | March 21, 2008 |
| Days to Decision | 465 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NDW — Assay, Porphyrin, Spectrophotometry, Lithium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3560 |