K821768 is an FDA 510(k) clearance for the EMIT ST URINE METHAGUALONE ASSAY. This device is classified as a Radioimmunoassay, Methaqualone (Class II - Special Controls, product code KXS).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1982, 9 days after receiving the submission on June 15, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3630.
| 510(k) Number | K821768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1982 |
| Decision Date | June 24, 1982 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KXS — Radioimmunoassay, Methaqualone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3630 |