Medical Device Manufacturer · US , Bothell , WA

Elitechgroup

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

Elitechgroup — FDA 510(k) Submissions

Elitechgroup has submitted 17 FDA 510(k) premarket notifications since 2011, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrator, Multi-analyte Mixture, U.v. Method, Cpk Isoenzymes, Diazo Colorimetry, Bilirubin, Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, Calibrator, Secondary . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
K180559 · PGI Herpes Virus (vzv, Hsv1,... · Microbiology
Oct 2018 242d
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
K171401 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jul 2017 60d
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
K153644 · CFR Hexokinase, Glucose · Chemistry
Sep 2016 261d
ELITech Clinical Systems CALCIUM ARSENAZO
K151113 · CJY Azo Dye, Calcium · Chemistry
Jul 2015 86d
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
K151552 · JIX Calibrator, Multi-analyte... · Chemistry
Jul 2015 29d
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
K141265 · JHW U.v. Method, Cpk Isoenzymes · Chemistry
Jul 2014 64d
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
K132399 · JFY Enzymatic Method, Creatinine · Chemistry
Jan 2014 155d
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
K130765 · JIX Calibrator, Multi-analyte... · Chemistry
Apr 2013 15d
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
K122177 · JIT Calibrator, Secondary · Chemistry
Feb 2013 207d
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
K122858 · JFJ Catalytic Methods, Amylase · Chemistry
Oct 2012 15d
ELITECH CLINICAL SYSTEMS CK NAC SL
K122083 · JHW U.v. Method, Cpk Isoenzymes · Chemistry
Aug 2012 37d
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
K113269 · CJE Nitrophenylphosphate,... · Chemistry
Dec 2011 55d
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
K111960 · KHS Enzymatic, Carbon-dioxide · Chemistry
Nov 2011 130d
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
K110780 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Oct 2011 200d
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
K111996 · JJY Multi-analyte Controls,... · Chemistry
Sep 2011 63d
ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
K112029 · JIX Calibrator, Multi-analyte... · Chemistry
Aug 2011 46d
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
K110830 · CIX Bromcresol Green... · Chemistry
Jun 2011 88d
Filters