The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dupont Aca Digoxin (dgn A) Method.
| Device ID | K951441 |
| 510k Number | K951441 |
| Device Name: | DUPONT ACA DIGOXIN (DGN A) METHOD |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 BARLEY MILL PLAZA, P22-1158 Wilmington, DE 19880 -0022 |
| Contact | Cathy P Craft |
| Correspondent | Cathy P Craft E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 BARLEY MILL PLAZA, P22-1158 Wilmington, DE 19880 -0022 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-29 |
| Decision Date | 1995-06-01 |