K874578 is an FDA 510(k) clearance for the EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY. 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 November 24, 1987, 18 days after receiving the submission on November 6, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K874578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1987 |
| Decision Date | November 24, 1987 |
| Days to Decision | 18 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 |