The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Urine Methadone Screen Flex(tm) Reagent Cartridge.
Device ID | K950182 |
510k Number | K950182 |
Device Name: | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE |
Classification | Hemagglutination Inhibition, Methadone |
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 | DIW |
CFR Regulation Number | 862.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-17 |
Decision Date | 1995-03-21 |