K821195 is an FDA 510(k) clearance for the CHOLESTEROL REAGENT SET. This device is classified as a Acid, Ferric Ion-sulfuric, Cholesterol (Class I - General Controls, product code CHD).
Submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982, 77 days after receiving the submission on April 27, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K821195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1982 |
| Decision Date | July 13, 1982 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHD — Acid, Ferric Ion-sulfuric, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |