The following data is part of a premarket notification filed by Syva Co. with the FDA for Modifica- Of Emit Aed Ethosuximide Assay.
| Device ID | K832797 |
| 510k Number | K832797 |
| Device Name: | MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY |
| Classification | Enzyme Immunoassay, Ethosuximide |
| Applicant | SYVA CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DLF |
| CFR Regulation Number | 862.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-18 |
| Decision Date | 1983-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768000140 | K832797 | 000 |