The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Aca(r) Digoxin Analytical Test Pack (dgn).
| Device ID | K932732 |
| 510k Number | K932732 |
| Device Name: | ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN) |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington, DE 19880 -0022 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 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 | 1993-06-07 |
| Decision Date | 1993-11-15 |