The following data is part of a premarket notification filed by Carolina Liquid Chemistries, Corp. with the FDA for Carolina Liquid Chemistries Cocaine And Cocaine Metabolite Enzyme Immunoassay (cocm) Test System.
Device ID | K213211 |
510k Number | K213211 |
Device Name: | Carolina Liquid Chemistries Cocaine And Cocaine Metabolite Enzyme Immunoassay (COCM) Test System |
Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
Applicant | Carolina Liquid Chemistries, Corp. 313 Gallimore Dairy Road Greensboro, NC 27409 |
Contact | Patricia A Shugart |
Correspondent | Philip G Shugart Carolina Liquid Chemistries, Corp. 313 Gallimore Dairy Road Greensboro, NC 27409 |
Product Code | DIO |
CFR Regulation Number | 862.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-29 |
Decision Date | 2022-01-27 |