K812003 is an FDA 510(k) clearance for the A-GENT THEOPHYLLINE. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 27, 1981, 13 days after receiving the submission on July 14, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K812003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1981 |
| Decision Date | July 27, 1981 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |