The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart (r) Electrolyte Reagent System.
| Device ID | K874185 |
| 510k Number | K874185 |
| Device Name: | DART (R) ELECTROLYTE REAGENT SYSTEM |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-14 |
| Decision Date | 1987-11-04 |