K913123 is an FDA 510(k) clearance for the EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on September 19, 1991, 66 days after receiving the submission on July 15, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K913123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1991 |
| Decision Date | September 19, 1991 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |