K041720 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II. This device is classified as a System, Test, Low Density, Lipoprotein (Class I - General Controls, product code MRR).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on August 25, 2004, 62 days after receiving the submission on June 24, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K041720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2004 |
| Decision Date | August 25, 2004 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRR — System, Test, Low Density, Lipoprotein |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |