CIB — Radioimmunoassay, Angiotensin I And Renin Class II

FDA Device Classification

Classification Details

Product Code
CIB
Device Class
Class II
Regulation Number
862.1085
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K123763immunodiagnostic systemsIDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRDecember 24, 2013
K121944diasorinLIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTJanuary 1, 2013
K062120cis bio internationalCISBIO RENIN RIA TESTMarch 30, 2007
K061758diagnostic systems laboratoriesACTIVE RENIN IRMAJuly 28, 2006
K011128nichols institute diagnosticsNICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, ANSeptember 6, 2001
K981607diagnostic systems laboratoriesACTIVE RENIN IRMA MODEL NUMBER DSL-25100May 27, 1998
K954299buhlmann laboratoriesBUHLMANN ANGIOSTENSIN II RIAOctober 19, 1995
K940004pharmarceutical discoveryAI-PHOTODIAGNOSTICAugust 4, 1995
K925998nichols institute diagnosticsACTIVE RENIN IMMUNORADIOMETRIC ASSAYJanuary 6, 1993
K850054e.i. dupont de nemours and coRIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KIMarch 29, 1985
K842966serono diagnosticsRENIN RADIOIMMUNOASSAY TEST KITOctober 11, 1984
K833777immuno-diagnostic laboratoriesANGIOTENSIN CONVERTING ENZYMEJanuary 30, 1984
K831694hoffmann-la rocheRENAKJuly 19, 1983
K820616e. r. squibb and sonsANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAYMarch 26, 1982
K800774sorin biomedica, fiat, usaRENCTKApril 21, 1980
K761267squibb and sonsANGIOTENSIN I IMMUTOPE KITDecember 30, 1976