Submission Details
| 510(k) Number | K042520 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
Nov 2004
Decision
75d
Days
Class 2
Risk
About This 510(k) Submission
K042520 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III, 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 review panel. Regulated under 21 CFR 862.3880.
Device Classification
| Product Code | KLS — Enzyme Immunoassay, Theophylline |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3880 |
Manufacturer
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