The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Phenytoin.
| Device ID | K880294 |
| 510k Number | K880294 |
| Device Name: | DART PHENYTOIN |
| Classification | Nephelometric Inhibition Immunoassay, Diphenylhydantoin |
| Applicant | COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Contact | A Richardson-jones |
| Correspondent | A Richardson-jones COULTER ELECTRONICS, INC. 745 WEST 83RD ST. Hialeah, FL 33014 |
| Product Code | LFO |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-25 |
| Decision Date | 1988-05-27 |