FDA.report

510(k) K823045

Device
KM-KAL L4
Applicant
KMN PRODUCTS, INC.
510(k) number
K823045
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

Related Records

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)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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