K864081 is an FDA 510(k) clearance for the U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on December 4, 1986, 45 days after receiving the submission on October 20, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K864081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1986 |
| Decision Date | December 04, 1986 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |