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 Cannabinoids (u Thc) Screen Meth.
Device ID | K875252 |
510k Number | K875252 |
Device Name: | ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH |
Classification | Enzyme Immunoassay, Cannabinoids |
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 | LDJ |
CFR Regulation Number | 862.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-22 |
Decision Date | 1988-02-03 |