The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Agglutex Methaqualone Test Kit.
| Device ID | K812987 |
| 510k Number | K812987 |
| Device Name: | AGGLUTEX METHAQUALONE TEST KIT |
| Classification | Radioimmunoassay, Methaqualone |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXS |
| CFR Regulation Number | 862.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-26 |
| Decision Date | 1981-12-22 |