The following data is part of a premarket notification filed by Syva / A Syntex Co. with the FDA for Acculevel Phenytoin Test.
| Device ID | K855026 |
| 510k Number | K855026 |
| Device Name: | ACCULEVEL PHENYTOIN TEST |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | SYVA / A SYNTEX CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Eleanor V Chiu |
| Correspondent | Eleanor V Chiu SYVA / A SYNTEX CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-08-25 |