The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Omni S Analyzer.
| Device ID | K032311 |
| 510k Number | K032311 |
| Device Name: | ROCHE DIAGNOSTICS OMNI S ANALYZER |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | ROCHE DIAGNOSTICS CORP. P.O. BOX 50457 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett ROCHE DIAGNOSTICS CORP. P.O. BOX 50457 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | CEM |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CHL |
| Subsequent Product Code | GGF |
| Subsequent Product Code | GGZ |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KHG |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-28 |
| Decision Date | 2003-10-17 |
| Summary: | summary |