K011771 is an FDA 510(k) clearance for the RANDOX THEOPHYLLINE. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 17, 2002, 225 days after receiving the submission on June 6, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K011771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2001 |
| Decision Date | January 17, 2002 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |