The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Cocaine Kit, Toxi-pak.
Device ID | K760401 |
510k Number | K760401 |
Device Name: | COCAINE KIT, TOXI-PAK |
Classification | Hemagglutination, Cocaine Metabolites (benzoylecgnonine) |
Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DLN |
CFR Regulation Number | 862.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-06 |
Decision Date | 1976-08-26 |