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 |