The following data is part of a premarket notification filed by Technam, Inc. with the FDA for Hi-m-test For Methadone Test #2.
| Device ID | K801509 |
| 510k Number | K801509 |
| Device Name: | HI-M-TEST FOR METHADONE TEST #2 |
| Classification | Hemagglutination Inhibition, Methadone |
| Applicant | TECHNAM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DIW |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-30 |
| Decision Date | 1980-07-14 |