The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit Qst Ethosuximide Assay.
| Device ID | K844204 |
| 510k Number | K844204 |
| Device Name: | EMIT QST ETHOSUXIMIDE ASSAY |
| Classification | Enzyme Immunoassay, Ethosuximide |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Joan Kurjian |
| Correspondent | Joan Kurjian SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | DLF |
| CFR Regulation Number | 862.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-30 |
| Decision Date | 1984-12-11 |