The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Gemlyte Electrolyte Analyzer Na+/k+/cl-/ca++/li+.
| Device ID | K082462 |
| 510k Number | K082462 |
| Device Name: | GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Liann Voo |
| Correspondent | Liann Voo DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JIH |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-27 |
| Decision Date | 2009-02-06 |
| Summary: | summary |