The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Digoxin Assay.
| Device ID | K864802 |
| 510k Number | K864802 |
| Device Name: | DART DIGOXIN ASSAY |
| Classification | Radioimmunoassay, Digoxin (125-i) |
| Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Product Code | LCS |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-02-12 |