K973988 is an FDA 510(k) clearance for the RDI HOMOGENEOUS HDL CHOLESTEROL TEST. This device is classified as a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I - General Controls, product code LBS).
Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on December 22, 1997, 62 days after receiving the submission on October 21, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K973988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1997 |
| Decision Date | December 22, 1997 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |