K042520 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III. This device is classified as a Enzyme Immunoassay, Theophylline (Class II - Special Controls, product code KLS).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 30, 2004, 75 days after receiving the submission on September 16, 2004.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3880.
| 510(k) Number | K042520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2004 |
| Decision Date | November 30, 2004 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3880 |