K812986 is an FDA 510(k) clearance for the AGGLUTEX AMPHETAMINE TEST KIT. This device is classified as a Radioimmunoassay, Amphetamine (Class II - Special Controls, product code DJP).
Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982, 88 days after receiving the submission on October 26, 1981.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.
| 510(k) Number | K812986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1981 |
| Decision Date | January 22, 1982 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJP — Radioimmunoassay, Amphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3100 |