The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas C 501 Ise Indirect Na, K, Cl For Gen. 2.
| Device ID | K132418 |
| 510k Number | K132418 |
| Device Name: | COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Khoa Tran |
| Correspondent | Khoa Tran Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| 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 | 2013-08-02 |
| Decision Date | 2013-12-18 |
| Summary: | summary |