The following data is part of a premarket notification filed by Diamond Diagnostics, Inc with the FDA for Prolyte Electrolyte Analyzer.
| Device ID | K121140 |
| 510k Number | K121140 |
| Device Name: | PROLYTE ELECTROLYTE ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | DIAMOND DIAGNOSTICS, INC 333 Fiske St Holliston, MA 01746 |
| Contact | Kathy Cruz |
| Correspondent | Kathy Cruz DIAMOND DIAGNOSTICS, INC 333 Fiske St Holliston, MA 01746 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JIH |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-16 |
| Decision Date | 2012-08-22 |
| Summary: | summary |