The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dupont Aca(r) Plus Immunoassay Sys Ferritin(ferr) Meth.
| Device ID | K935528 |
| 510k Number | K935528 |
| Device Name: | DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 Wilmington, DE 19880 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 Wilmington, DE 19880 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1994-01-28 |