The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Aca Urine Benzodiazepines (ubenz) Screen Method.
| Device ID | K873538 |
| 510k Number | K873538 |
| Device Name: | ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| 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 | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-01 |
| Decision Date | 1987-10-02 |