FDA.reportPublic FDA data

Bryce McEuen

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30076629743007662974Bryce McEuen1N2020-04-25370 West 1700 South Logan UT US 84321

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1031261143812424K945271ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEMJJE1995-04-20
1031261916447845K941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808CJY1994-05-13
1031261654711287K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1CIG2017-07-11
1031261407996509K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IICFR2016-09-07
1031261593024159K151113ELITech Clinical Systems CALCIUM ARSENAZOCJY2015-07-22
1031261242495380K141265ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KITJHW2014-07-18
1031261765230339K132399ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVELJFY2014-01-03
1031261641827205K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIJFJ2012-10-03
1031261601576612K122177ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVELJIT2013-02-15
1031261909947224K122083ELITECH CLINICAL SYSTEMS CK NAC SLJHW2012-08-22
1031261186514342K120202EON CHOLESTEROL REAGENTCHH2012-07-27
1031261521804864K113269ELITTECH CLINICAL SYSTEMS ALP IFCC SLCJE2011-12-29
1031261162737520K111996ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2JJY2011-09-14
1031261234347663K111960ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORSKHS2011-11-18
1031261147790785K111063VITAL SERUM CONTROLSJJY2011-06-28
1031261139419925K110830ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECHCIX2011-06-21
1031261627669594K110780ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & IICIG2011-10-07
1031261980508967K110394ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)JIX2011-06-09
1031261664566868K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSLBS2011-08-31
1031261662192771K103376ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CLJFY2011-11-18
1031261300394490K102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLCDT2011-05-19
1031261118086861K102647ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...JGS2011-03-24
1031261945504775K100547ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICALLCP2011-05-19
1031261738989693K100525ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2CGA2010-12-15
1031261752158664K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSCEO2011-05-06
1031261122060446K100060EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475KHS2010-12-15
1031261580041609K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-CIT2010-09-20
1031261386633780K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)LBS2007-12-20
1031261827297864K040631VITALAB DIRECT BILIRUBIN REAGENTCIG2004-03-18
1031261868947396K040508VITALAB MAGNESIUM REAGENTJGJ2004-03-08
1031261848256171K040467VITALAB URIC ACID REAGENTKNK2004-03-08
1031261907829884K033983VITALAB IRON REAGENTJIY2004-05-21
1031261994185863K023407ATAC PAK CREATININE REAGENT AND ATAC CALIBRATORCGX2003-02-14
1031261548261394K020575ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITSMRR2002-04-12
1031261022137742K010488ATAC PAK AST REAGENT KITCIT2001-04-09
1031261172000176K002285ATAC PAK ALP REAGENT KITCJE2000-09-26
1031261379227356
1031261396987021
1031261555867034
1031261572863082
1031261904119171

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CIG32017-07-11
CJY22015-07-22
JHW22014-07-18
JFY22014-01-03
CJE22011-12-29
KHS22011-11-18
JJY22011-09-14
LBS22011-08-31
CIT22010-09-20
CFR12016-09-07
JIT12013-02-15
JFJ12012-10-03
CHH12012-07-27
CIX12011-06-21
JIX12011-06-09
LCP12011-05-19
CDT12011-05-19
CEO12011-05-06
JGS12011-03-24
CGA12010-12-15
JIY12004-05-21
JGJ12004-03-08
KNK12004-03-08
CGX12003-02-14
MRR12002-04-12
JJE11995-04-20