The following data is part of a premarket notification filed by Carolina Liquid Chemistries Corporation with the FDA for Carolina Liquid Chemistries Cocaine And Cocaine Metabolite Test System (cocm).
| Device ID | K163570 |
| 510k Number | K163570 |
| Device Name: | Carolina Liquid Chemistries Cocaine And Cocaine Metabolite Test System (COCM) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Carolina Liquid Chemistries Corporation 575 North Patterson Avenue, Suite 430 Winston-salem, NC 27101 |
| Contact | Mica A. Welsh |
| Correspondent | Mica A. Welsh Carolina Liquid Chemistries Corporation 575 North Patterson Avenue, Suite 430 Winston-salem, NC 27101 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-08-15 |
| Summary: | summary |