K123763 is an FDA 510(k) clearance for the IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS. This device is classified as a Radioimmunoassay, Angiotensin I And Renin (Class II - Special Controls, product code CIB).
Submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on December 24, 2013, 382 days after receiving the submission on December 7, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1085.
| 510(k) Number | K123763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2012 |
| Decision Date | December 24, 2013 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIB — Radioimmunoassay, Angiotensin I And Renin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1085 |