FDA.reportPublic FDA data

510(k) K112834

Device
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
Applicant
VERICHEM LABORATORIES, INC.
510(k) number
K112834
Product code
JIX  
Decision
Substantially Equivalent (SESE)
Decision date
2012-03-28
Date received
2011-09-28
Regulation
862.1150
Classification name
Calibrator, Multi-analyte Mixture
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANTHONY JAMES DIMONTE
Address
90 Narragansett Ave. Providence RI US 02907 02907

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K103171ELECSYS ANTI-TPO CALSETRoche Diagnostics2011-02-11

Legacy Summary#

summary

FDA Review#

Decision Summary