K893740 is an FDA 510(k) clearance for the LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES. This device is classified as a System, Test, Low Density, Lipoprotein (Class I - General Controls, product code MRR).
Submitted by Reference Diagnostics, Inc. (Arlington, US). The FDA issued a Cleared decision on March 19, 1990, 306 days after receiving the submission on May 17, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K893740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1989 |
| Decision Date | March 19, 1990 |
| Days to Decision | 306 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | MRR — System, Test, Low Density, Lipoprotein |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |