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510(k) K844955

Device
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
Applicant
MILES LABORATORIES, INC.
510(k) number
K844955
Product code
CEM  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-19
Date received
1984-12-21
Regulation
862.1600
Classification name
Electrode, Ion Specific, Potassium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN H ENGELMANN
Address
1127 Myrtle St. P.O. Box 40 Elkhart IN US 46514 46514

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K112995GEM PREMIER 4000Instrumentation Laboratory CO2012-05-03
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

Legacy Summary#

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FDA Review#

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