The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Cocaine Dipstick Test, Model D747-a.
| Device ID | K010239 |
| 510k Number | K010239 |
| Device Name: | COCAINE DIPSTICK TEST, MODEL D747-A |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Dindo Carrillo |
| Correspondent | Dindo Carrillo TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-25 |
| Decision Date | 2001-06-25 |