The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dacos Plus Lytes Option.
| Device ID | K843239 |
| 510k Number | K843239 |
| Device Name: | DACOS PLUS LYTES OPTION |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | COULTER ELECTRONICS, INC. 590 WEST 20TH ST. Hialeah, FL 33010 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 590 WEST 20TH ST. Hialeah, FL 33010 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-22 |
| Decision Date | 1984-10-17 |