FDA.reportPublic FDA data

510(k) K771526

Device
125 I ALDOSTERONE RIA KIT
Applicant
Diagnostic Products Corp.
510(k) number
K771526
Product code
CJM
Decision
Substantially Equivalent (SESE)
Decision date
1977-08-25
Date received
1977-08-08
Regulation
862.1045
Classification name
Radioimmunoassay, Aldosterone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CJM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration VerifiersImmunodiagnostic Systems , Ltd.2015-04-21
K130321LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERSDiasorin2013-04-09
K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYNichols Institute Diagnostics2005-06-01
K032188NICHOLS ADVANTAGE ALDOSTERONE ASSAYNichols Institute Diagnostics2003-07-31
K943397DSL ACTIVE ALDOSTERONE RIA (DSL 8600)Diagnostic Systems Laboratories, Inc.1995-02-13
K921205DSL ACTIVE ALDOSTERONE (DSL 8600)Diagnostic Systems Laboratories, Inc.1992-07-10
K862204RSL (125I) ALDOSTERONE KITRadioassay Systems Laboratories, Inc.1986-09-25
K834428ALDOSTERONE RADIOIMMUNOASSAY TEST KITSerono Laboratories, Inc.1984-03-02
K831178COAT-A-COUNT NO-EXTRACTION ALDOSTERONEDiagnostic Products Corp.1983-05-27
K800775ALDOCTK-125Sorin Biomedica, Fiat, USA, Inc.1980-04-21
K781504125I-ALDOSTERONE RIA DIAG. KITAbbott Laboratories1978-11-22