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510(k) K823046

Device
KM-KAL L5
Applicant
KMN PRODUCTS, INC.
510(k) number
K823046
Product code
JIX  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-05
Date received
1982-10-15
Regulation
862.1150
Classification name
Calibrator, Multi-analyte Mixture
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

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 JIX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.2016-05-20
K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc.2015-12-18
K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIElitechgroup2015-07-08
K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics2015-06-15
K141388SYSTEM CALIBRATERBeckman Coulter Ireland, Inc.2014-07-11
K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche Diagnostics2013-11-26
K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroup2013-04-04
K123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare Diagnostics2013-02-15
K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott Laboratories2013-01-14
K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.2012-10-12
K112834MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLESVerichem Laboratories, Inc.2012-03-28
K112029ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05Elitechgroup2011-08-30
K110394ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)Vital Diagnostics (Manufacturing) Ptyltd2011-06-09
K110251SYNCHRON MULTI CALIBRATORBeckman Coulter, Inc.2011-05-25
K103701ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORSSiemens Healthcare Diagnostics, Inc.2011-02-18

Legacy Summary#

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FDA Review#

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