K813240 is an FDA 510(k) clearance for the EMIT-AAD THEOPHYLLINE ASSAY. This device is classified as a Fluorescent Immunoassay, Theophylline (Class II - Special Controls, product code LER).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981, 16 days after receiving the submission on November 17, 1981.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K813240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1981 |
| Decision Date | December 03, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LER — Fluorescent Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |