K910697 is an FDA 510(k) clearance for the IL THEOPHYLLINE ASSAY SYSTEM. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on April 3, 1991, 43 days after receiving the submission on February 19, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K910697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1991 |
| Decision Date | April 03, 1991 |
| Days to Decision | 43 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 |