K914469 is an FDA 510(k) clearance for the CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG 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 October 30, 1991, 23 days after receiving the submission on October 7, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K914469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1991 |
| Decision Date | October 30, 1991 |
| Days to Decision | 23 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 |