K885253 is an FDA 510(k) clearance for the ACCULEVEL ONE-STEP 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 31, 1989, 98 days after receiving the submission on December 23, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K885253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1988 |
| Decision Date | March 31, 1989 |
| Days to Decision | 98 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 |