FDA.reportPublic FDA data

510(k) K011128

Device
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
Applicant
Nichols Institute Diagnostics
510(k) number
K011128
Product code
CIB
Decision
Substantially Equivalent (SESE)
Decision date
2001-09-06
Date received
2001-04-13
Regulation
862.1085
Classification name
Radioimmunoassay, Angiotensin I And Renin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JIMMY WONG
Address
33051 Calle Aviador San Juan Capistrano CA US 92675 92675

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CIB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123763IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSImmunodiagnostic Systems , Ltd.2013-12-24
K121944LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTDiaSorin, Inc.2013-01-01
K062120CISBIO RENIN RIA TESTCis Bio International2007-03-30
K061758ACTIVE RENIN IRMADiagnostic Systems Laboratories, Inc.2006-07-28
K981607ACTIVE RENIN IRMA MODEL NUMBER DSL-25100Diagnostic Systems Laboratories, Inc.1998-05-27
K954299BUHLMANN ANGIOSTENSIN II RIABuhlmann Laboratories AG1995-10-19
K940004AI-PHOTODIAGNOSTICPharmarceutical Discovery Corp.1995-08-04
K925998ACTIVE RENIN IMMUNORADIOMETRIC ASSAYNichols Institute Diagnostics1993-01-06
K850054RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KIE.I. Dupont DE Nemours & Co., Inc.1985-03-29
K842966RENIN RADIOIMMUNOASSAY TEST KITSerono Diagnostics, Inc.1984-10-11
K833777ANGIOTENSIN CONVERTING ENZYMEImmuno-Diagnostic Laboratories1984-01-30
K831694RENAKHoffmann-La Roche, Inc.1983-07-19
K820616ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAYE. R. Squibb & Sons, Inc.1982-03-26
K800774RENCTKSorin Biomedica, Fiat, USA, Inc.1980-04-21
K761267ANGIOTENSIN I IMMUTOPE KITSquibb & Sons, Inc.1976-12-30