K855227 is an FDA 510(k) clearance for the MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Bioclinical Systems, Inc. (St.Louis, US). The FDA issued a Cleared decision on April 11, 1986, 102 days after receiving the submission on December 30, 1985.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K855227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1985 |
| Decision Date | April 11, 1986 |
| Days to Decision | 102 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 |