K844170 is an FDA 510(k) clearance for the THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 11, 1984, 47 days after receiving the submission on October 25, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K844170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1984 |
| Decision Date | December 11, 1984 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |