K121944 is an FDA 510(k) clearance for the LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT. This device is classified as a Radioimmunoassay, Angiotensin I And Renin (Class II - Special Controls, product code CIB).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on January 1, 2013, 182 days after receiving the submission on July 3, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1085.
| 510(k) Number | K121944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2012 |
| Decision Date | January 01, 2013 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIB — Radioimmunoassay, Angiotensin I And Renin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1085 |