The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Determination Of Phenytoin (diphenylhydantoin).
| Device ID | K860048 |
| 510k Number | K860048 |
| Device Name: | DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN) |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston, MA 02134 |
| Contact | Israel M Stein,m.d. |
| Correspondent | Israel M Stein,m.d. CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston, MA 02134 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-01-22 |