Medical Device Manufacturer · US , Bothell , WA

Elitechgroup - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2011
17
Total
17
Cleared
0
Denied

Elitechgroup has 17 FDA 510(k) cleared chemistry devices. Based in Bothell, US.

Historical record: 17 cleared submissions from 2011 to 2018.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Elitechgroup

17 devices
1-17 of 17
Cleared Oct 29, 2018
HSV 1 & 2 ELITe MGB Kit
K180559 · PGI
Microbiology · 242d
Cleared Jul 11, 2017
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems...
K171401 · CIG
Chemistry · 60d
Cleared Sep 07, 2016
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2,...
K153644 · CFR
Chemistry · 261d
Cleared Jul 22, 2015
ELITech Clinical Systems CALCIUM ARSENAZO
K151113 · CJY
Chemistry · 86d
Cleared Jul 08, 2015
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I,...
K151552 · JIX
Chemistry · 29d
Cleared Jul 18, 2014
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
K141265 · JHW
Chemistry · 64d
Cleared Jan 03, 2014
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL...
K132399 · JFY
Chemistry · 155d
Cleared Apr 04, 2013
ELITECH CLINICAL SYSTEMS ELICAL 2
K130765 · JIX
Chemistry · 15d
Cleared Feb 15, 2013
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH...
K122177 · JIT
Chemistry · 207d
Cleared Oct 03, 2012
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH...
K122858 · JFJ
Chemistry · 15d
Cleared Aug 22, 2012
ELITECH CLINICAL SYSTEMS CK NAC SL
K122083 · JHW
Chemistry · 37d
Cleared Dec 29, 2011
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
K113269 · CJE
Chemistry · 55d
Cleared Nov 18, 2011
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS...
K111960 · KHS
Chemistry · 130d
Cleared Oct 07, 2011
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL...
K110780 · CIG
Chemistry · 200d
Cleared Sep 14, 2011
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
K111996 · JJY
Chemistry · 63d
Cleared Aug 30, 2011
ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I,...
K112029 · JIX
Chemistry · 46d
Cleared Jun 21, 2011
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO
K110830 · CIX
Chemistry · 88d
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