K944975 is an FDA 510(k) clearance for the MAGNETIC HDL CHOLESTEROL TEST. This device is classified as a Ldl & Vldl Precipitation, Hdl (Class I - General Controls, product code LBR).
Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on August 2, 1995, 295 days after receiving the submission on October 11, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K944975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1994 |
| Decision Date | August 02, 1995 |
| Days to Decision | 295 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 |