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 |