The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca Ethosurimide Test Pack.
| Device ID | K792584 |
| 510k Number | K792584 |
| Device Name: | ACA ETHOSURIMIDE TEST PACK |
| Classification | Enzyme Immunoassay, Ethosuximide |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. 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 | 1979-12-14 |
| Decision Date | 1979-12-31 |