IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS

Radioimmunoassay, Angiotensin I And Renin

IMMUNODIAGNOSTIC SYSTEMS LTD.

The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, And Ids Isys Direct Renin Calibration Verifiers.

Pre-market Notification Details

Device IDK123763
510k NumberK123763
Device Name:IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
ClassificationRadioimmunoassay, Angiotensin I And Renin
Applicant IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear,  GB Ne35 9pd
ContactMick Fenton
CorrespondentMick Fenton
IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear,  GB Ne35 9pd
Product CodeCIB  
CFR Regulation Number862.1085 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-07
Decision Date2013-12-24

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