The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Urine Amphetamines Screen Flex(tm) Reagent Cartridge.
| Device ID | K950135 |
| 510k Number | K950135 |
| Device Name: | URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19880 -0022 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George E.I. DUPONT DE NEMOURS & CO., INC. P.O. BOX 80022 BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19880 -0022 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-13 |
| Decision Date | 1995-03-30 |