K984303 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT. This device is classified as a Ldl & Vldl Precipitation, Hdl (Class I - General Controls, product code LBR).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 28, 1999, 57 days after receiving the submission on December 2, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K984303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1998 |
| Decision Date | January 28, 1999 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LBR — Ldl & Vldl Precipitation, Hdl |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |