K911578 is an FDA 510(k) clearance for the CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION. 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 May 15, 1991, 49 days after receiving the submission on March 27, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K911578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1991 |
| Decision Date | May 15, 1991 |
| Days to Decision | 49 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 |