The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca Digoxin Analytical Test Pack.
| Device ID | K930162 |
| 510k Number | K930162 |
| Device Name: | ACA DIGOXIN ANALYTICAL TEST PACK |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 Wilmington, DE 19880 |
| Contact | George B Mckeown |
| Correspondent | George B Mckeown E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 Wilmington, DE 19880 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-13 |
| Decision Date | 1993-03-10 |