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

FDA 510(k) Number Applicant Device Name Decision Date
K954299 BUHLMANN LABORATORIES AG BUHLMANN ANGIOSTENSIN II RIA 10/19/1995
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
K820616 E. R. SQUIBB & SONS, INC. ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY 03/26/1982
K850054 E.I. DUPONT DE NEMOURS & CO., INC. RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI 03/29/1985
K831694 HOFFMANN-LA ROCHE, INC. RENAK 07/19/1983
K833777 IMMUNO-DIAGNOSTIC LABORATORIES ANGIOTENSIN CONVERTING ENZYME 01/30/1984
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
K925998 NICHOLS INSTITUTE DIAGNOSTICS ACTIVE RENIN IMMUNORADIOMETRIC ASSAY 01/06/1993
K011128 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) 09/06/2001
K940004 PHARMARCEUTICAL DISCOVERY CORP. AI-PHOTODIAGNOSTIC 08/04/1995
K842966 SERONO DIAGNOSTICS, INC. RENIN RADIOIMMUNOASSAY TEST KIT 10/11/1984
K800774 SORIN BIOMEDICA, FIAT, USA, INC. RENCTK 04/21/1980
K761267 SQUIBB & SONS, INC. ANGIOTENSIN I IMMUTOPE KIT 12/30/1976


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