The following data is part of a premarket notification filed by Osmetech, Inc. with the FDA for Opti Lion Electrolyte Analyzer, Model Gd7200.
| Device ID | K052027 |
| 510k Number | K052027 |
| Device Name: | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | OSMETECH, INC. 235 HEMBREE PARK DRIVE Roswell, GA 30076 |
| Contact | Daniel Mcminn |
| Correspondent | Daniel Mcminn OSMETECH, INC. 235 HEMBREE PARK DRIVE Roswell, GA 30076 |
| Product Code | CGZ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CHL |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-27 |
| Decision Date | 2005-09-29 |
| Summary: | summary |