The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca Du Pont Urine Cocaine Metabolite (u Coc)screen.
| Device ID | K874213 |
| 510k Number | K874213 |
| Device Name: | ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Grace H Singles |
| Correspondent | Grace H Singles E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-16 |
| Decision Date | 1987-11-13 |