Elitechgroup - FDA 510(k) Cleared Devices
Recent clearances: HSV 1 & 2 ELITe MGB Kit
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elitechgroup Chemistry ✕
16 devices
Cleared
Jul 11, 2017
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems...
Chemistry
60d
Cleared
Sep 07, 2016
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2,...
Chemistry
261d
Cleared
Jul 22, 2015
ELITech Clinical Systems CALCIUM ARSENAZO
Chemistry
86d
Cleared
Jul 08, 2015
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I,...
Chemistry
29d
Cleared
Jul 18, 2014
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
Chemistry
64d
Cleared
Jan 03, 2014
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL...
Chemistry
155d
Cleared
Apr 04, 2013
ELITECH CLINICAL SYSTEMS ELICAL 2
Chemistry
15d
Cleared
Feb 15, 2013
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH...
Chemistry
207d
Cleared
Oct 03, 2012
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH...
Chemistry
15d
Cleared
Aug 22, 2012
ELITECH CLINICAL SYSTEMS CK NAC SL
Chemistry
37d
Cleared
Dec 29, 2011
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
Chemistry
55d
Cleared
Nov 18, 2011
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS...
Chemistry
130d