K844642 is an FDA 510(k) clearance for the ACCULEVEL THEOPHYLLINE TEST. 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 March 19, 1985, 111 days after receiving the submission on November 28, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K844642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1984 |
| Decision Date | March 19, 1985 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |