FDA 510(k) Applications for Medical Device Product Code "CIB"
(Radioimmunoassay, Angiotensin I And Renin)

FDA 510(k) Number Applicant Device Name Decision Date
K062120 CIS BIO INTERNATIONAL CISBIO RENIN RIA TEST 03/30/2007
K061758 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE RENIN IRMA 07/28/2006
K981607 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 05/27/1998
K121944 DIASORIN, INC. LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT 01/01/2013
K123763 IMMUNODIAGNOSTIC SYSTEMS LTD. IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS 12/24/2013
K011128 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) 09/06/2001


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