FDA 510(k) Applications Submitted by ELITECHGROUP

FDA 510(k) Number Submission Date Device Name Applicant
K130765 03/20/2013 ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II ELITECHGROUP
K110830 03/25/2011 ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH ELITECHGROUP
K141265 05/15/2014 ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT ELITECHGROUP
K111960 07/11/2011 ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS ELITECHGROUP
K111996 07/13/2011 ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 ELITECHGROUP
K112029 07/15/2011 ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 ELITECHGROUP
K122083 07/16/2012 ELITECH CLINICAL SYSTEMS CK NAC SL ELITECHGROUP
K122177 07/23/2012 ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL ELITECHGROUP
K122858 09/18/2012 ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II ELITECHGROUP
K113269 11/04/2011 ELITTECH CLINICAL SYSTEMS ALP IFCC SL ELITECHGROUP
K151113 04/27/2015 ELITech Clinical Systems CALCIUM ARSENAZO ELITechGroup
K171401 05/12/2017 ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 ELITechGroup
K151552 06/09/2015 ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II ELITechGroup
K153644 12/21/2015 ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II ELITechGroup


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