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VitalScientific

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30076629743007662974VitalScientific1N2026-01-01Zone Industrielle 13 rue Auguste Mottin SEES Normandie FR 61500

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3290441330094436K945271ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEMJJE1995-04-20
3290442061085190K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1CIG2017-07-11
3290441404500168K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IICFR2016-09-07
3290441145318592K151113ELITech Clinical Systems CALCIUM ARSENAZOCJY2015-07-22
3290441897947069K141265ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KITJHW2014-07-18
3290441516862504K132399ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVELJFY2014-01-03
3290441790329692K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIJFJ2012-10-03
3290441341318195K122177ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVELJIT2013-02-15
3290441932158605K122083ELITECH CLINICAL SYSTEMS CK NAC SLJHW2012-08-22
3290441768262356K113269ELITTECH CLINICAL SYSTEMS ALP IFCC SLCJE2011-12-29
3290441792856889K111996ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2JJY2011-09-14
3290441716316497K111960ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORSKHS2011-11-18
3290441942542016K111063VITAL SERUM CONTROLSJJY2011-06-28
3290441944263262K110830ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECHCIX2011-06-21
3290441137502979K110780ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & IICIG2011-10-07
3290441442407132K110394ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)JIX2011-06-09
3290441360519565K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSLBS2011-08-31
3290441559346799K103376ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CLJFY2011-11-18
3290441678437599K102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLCDT2011-05-19
3290441101772516K102647ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...JGS2011-03-24
3290441027257854K100547ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICALLCP2011-05-19
3290441027052730K100525ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2CGA2010-12-15
3290441729951724K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSCEO2011-05-06
3290441203753128K093883AST/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
3290441672574222K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)LBS2007-12-20
3290441866530094K040631VITALAB DIRECT BILIRUBIN REAGENTCIG2004-03-18
3290441019403461K040508VITALAB MAGNESIUM REAGENTJGJ2004-03-08
3290441658741102K040467VITALAB URIC ACID REAGENTKNK2004-03-08
3290441165734943K033983VITALAB IRON REAGENTJIY2004-05-21
3290441912993848K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
3290441483697604K020575ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITSMRR2002-04-12
3290441919717987K010488ATAC PAK AST REAGENT KITCIT2001-04-09
3290441354642170K002285ATAC PAK ALP REAGENT KITCJE2000-09-26
3290441075907200
3290441192814402
3290441476755882
3290441726830460
3290441829274360
3290441852887620
3290441857709269
3290441889594875
3290442017948992

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CIG32017-07-11
JHW22014-07-18
JFY22014-01-03
CJE22011-12-29
JJY22011-09-14
LBS22011-08-31
LCP22011-05-19
CIT22010-09-20
CFR12016-09-07
CJY12015-07-22
JIT12013-02-15
JFJ12012-10-03
KHS12011-11-18
CIX12011-06-21
JIX12011-06-09
CDT12011-05-19
CEO12011-05-06
JGS12011-03-24
CGA12010-12-15
JIY12004-05-21
JGJ12004-03-08
KNK12004-03-08
MRR12002-04-12
JJE11995-04-20

GUDID#

200 records. Showing 1-40. Next