The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Agglutex Amphetamine Test Kit.
| Device ID | K812986 |
| 510k Number | K812986 |
| Device Name: | AGGLUTEX AMPHETAMINE TEST KIT |
| Classification | Radioimmunoassay, Amphetamine |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DJP |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-26 |
| Decision Date | 1982-01-22 |