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510(k) K850054

Device
Rianen Angiotensin I Radioimmunoassay Ki
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
510(k) number
K850054
Product code
CIB
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-29
Date received
1985-01-08
Regulation
862.1085
Classification name
Radioimmunoassay, Angiotensin I And Renin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SCHUTTENBURG
Address
331 Treble Cove Rd. N. Billerica MA US 01862 01862

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K011128NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)Nichols Institute Diagnostics2001-09-06
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
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