K142994 is an FDA 510(k) clearance for the IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers. This device is classified as a Radioimmunoassay, Aldosterone (Class II - Special Controls, product code CJM).
Submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on April 21, 2015, 187 days after receiving the submission on October 16, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1045.
| 510(k) Number | K142994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2014 |
| Decision Date | April 21, 2015 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJM — Radioimmunoassay, Aldosterone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1045 |