The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Dupont Dimension(r) Gentamicin(gent) Method.
| Device ID | K904305 |
| 510k Number | K904305 |
| Device Name: | DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD |
| Classification | Enzyme Immunoassay, Gentamicin |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Richard M Vaught |
| Correspondent | Richard M Vaught E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | LCD |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-19 |
| Decision Date | 1990-10-15 |