K011166 is an FDA 510(k) clearance for the MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 10, 2001, 24 days after receiving the submission on April 16, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K011166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2001 |
| Decision Date | May 10, 2001 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |