The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Chloride Elctrode Gen.2.
| Device ID | K060108 |
| 510k Number | K060108 |
| Device Name: | COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Corina Harper |
| Correspondent | Corina Harper ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | CGZ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-13 |
| Decision Date | 2006-02-16 |
| Summary: | summary |