The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas 8000 Ise Indirect Na, K, Ci For Gen. 2.
| Device ID | K123726 |
| 510k Number | K123726 |
| Device Name: | COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | David Tribbett |
| Correspondent | David Tribbett Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-04 |
| Decision Date | 2013-05-21 |
| Summary: | summary |