The following data is part of a premarket notification filed by General Diagnostics with the FDA for Cocaine Metabolite Enzyme Immunoassay Kit.
| Device ID | K871305 |
| 510k Number | K871305 |
| Device Name: | COCAINE METABOLITE ENZYME IMMUNOASSAY KIT |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck, NY 11021 |
| Contact | Susan M Durham |
| Correspondent | Susan M Durham GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck, NY 11021 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-01 |
| Decision Date | 1987-06-05 |