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 |
K180559 |
03/01/2018 |
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius |
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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