The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Ise Indirect Na, K, Cl For Gen.2.
| Device ID | K053165 |
| 510k Number | K053165 |
| Device Name: | ISE INDIRECT NA, K, CL FOR GEN.2 |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Contact | Kerwin Kaufman |
| Correspondent | Kerwin Kaufman ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2005-12-14 |
| Summary: | summary |