K862204 is an FDA 510(k) clearance for the RSL (125I) ALDOSTERONE KIT. This device is classified as a Radioimmunoassay, Aldosterone (Class II - Special Controls, product code CJM).
Submitted by Radioassay Systems Laboratories, Inc. (Carson, US). The FDA issued a Cleared decision on September 25, 1986, 107 days after receiving the submission on June 10, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1045.
| 510(k) Number | K862204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1986 |
| Decision Date | September 25, 1986 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CJM — Radioimmunoassay, Aldosterone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1045 |