K946065 is an FDA 510(k) clearance for the TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH).
Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on February 22, 1995, 99 days after receiving the submission on November 15, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K946065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1994 |
| Decision Date | February 22, 1995 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1175 |