The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Lithium.
| Device ID | K063684 |
| 510k Number | K063684 |
| Device Name: | COBAS LITHIUM |
| Classification | Assay, Porphyrin, Spectrophotometry, Lithium |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa Ambrose Bush |
| Correspondent | Theresa Ambrose Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | NDW |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-12 |
| Decision Date | 2008-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121382 | K063684 | 000 |