FDA.reportPublic FDA data

510(k) K112995

Device
GEM PREMIER 4000
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K112995
Product code
CEM  
Decision
Substantially Equivalent (SESE)
Decision date
2012-05-03
Date received
2011-10-07
Regulation
862.1600
Classification name
Electrode, Ion Specific, Potassium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CARL MARBLE
Address
526 Rte. 303 Orangeburg NY US 10962 10962

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CEM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche Diagnostics2026-02-12
K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps2025-01-14
K220396EasyStat 300Medica Corporation2023-09-26
K230890ISE ElectrodesRandox Laboratories, Ltd.2023-09-08
K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.2020-10-01
K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.2012-08-31
K121040SMARTLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.2012-08-30
K110520BIOLIS 12ITokyo Boeki Medisys, Inc.2012-03-23
K112412AU5800(R) CHEMISTRY ANALYZERBeckman Coulter, Inc.2011-12-23
K112408POLY-CHEM 90 ISE MODULEPolymedco, Inc.2011-11-04
K112788EASTLYTE NA/K/CA/PHMedica Corp.2011-10-20
K092686ABL90 FLEX SERIESRadiometer Medical Aps2010-08-06
K092849BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZEREpocal, Inc.2010-03-30
K093318ACCELERATOR APSAbbott Laboratories2010-02-19
K083680VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258Ortho-Clinical Diagnostics, Inc.2009-02-27

Legacy Summary#

summary

FDA Review#

Decision Summary