The following data is part of a premarket notification filed by Tecknam, Inc. with the FDA for Him Test Cocaine.
| Device ID | K792429 |
| 510k Number | K792429 |
| Device Name: | HIM TEST COCAINE |
| Classification | Hemagglutination, Cocaine Metabolites (benzoylecgnonine) |
| Applicant | TECKNAM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DLN |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-28 |
| Decision Date | 1979-12-07 |