K850938 is an FDA 510(k) clearance for the CHOLESTEROL. This device is classified as a Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol (Class I - General Controls, product code CGO).
Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 25, 1985, 110 days after receiving the submission on March 7, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K850938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1985 |
| Decision Date | June 25, 1985 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGO — Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |