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 Opiates (u Opi) Screen Method.
| Device ID | K872391 |
| 510k Number | K872391 |
| Device Name: | ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-19 |
| Decision Date | 1987-08-10 |