K792062 is an FDA 510(k) clearance for the THEOPHYLLINE RIASSAY. This device is classified as a Radioimmunoassay, Theophylline (Class II - Special Controls, product code LCA).
Submitted by Ria Diagnostics (Mchenry, US). The FDA issued a Cleared decision on February 25, 1980, 133 days after receiving the submission on October 15, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K792062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1979 |
| Decision Date | February 25, 1980 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCA — Radioimmunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |