The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms Tm- Phenytoin.
| Device ID | K904815 |
| 510k Number | K904815 |
| Device Name: | QMS TM- PHENYTOIN |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Michael J Sullivan |
| Correspondent | Michael J Sullivan SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1990-11-06 |