K830461 is an FDA 510(k) clearance for the ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE. This device is classified as a Radioimmunoassay, Methaqualone (Class II - Special Controls, product code KXS).
Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983, 37 days after receiving the submission on February 15, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3630.
| 510(k) Number | K830461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 1983 |
| Decision Date | March 24, 1983 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KXS — Radioimmunoassay, Methaqualone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3630 |