The following data is part of a premarket notification filed by Medtest Dx with the FDA for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay.
| Device ID | K191638 |
| 510k Number | K191638 |
| Device Name: | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | MedTest Dx 5449 Research Drive Canton, MI 48188 |
| Contact | William Cripps |
| Correspondent | William Cripps MedTest Dx 5449 Research Drive Canton, MI 48188 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-19 |
| Decision Date | 2020-03-12 |