K881257 is an FDA 510(k) clearance for the EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on May 27, 1988, 65 days after receiving the submission on March 23, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K881257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1988 |
| Decision Date | May 27, 1988 |
| Days to Decision | 65 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 |