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HORIBA ABX SAS

Matched from indexed company URL: HORIBA ABX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30001488793000148879HORIBA ABX SAS1N2026-01-01PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER Herault FR 34184

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
182431764106560K992511ABX PENTRA 60 HEMATOLOGY ANALYZERGKZ1999-10-15
182432070192098K955925CBC-CAL PLUS HEMATOLOGY CALIBRATORKRX1996-02-29
182431070054663K943336RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLEJPK1994-12-12
182431673359467K880616MINOS AUTOMATIC CELL COUNTERGKZ1988-05-02
182431061387676K843962CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLEJPK1984-11-01
182431989078682K232946Yumizen H2500GKZ2024-05-21
182431931772060K193649Yumizen C1200 Creatinine PAPJFY2021-05-10
182431422729847K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MCZP2020-06-26
182431264667288K191993Yumizen C1200 CRPDCK2019-10-03
182431557909517K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF2020-03-06
182431794713581K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJY2019-07-26
182431117657268K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE2019-08-30
182431167626625K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeJJE2019-02-12
182431626453560K151133PENTRA XLRGKZ2015-12-09
182431159758907K141161ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)GKZ2014-12-20
182431659955009K133676ABX PENTRA MICRO ALB CONTROL L/HJJY2014-07-11
182431127011516K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTCJY2013-07-03
182431378089838K110530ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROLCGX2012-04-30
182431499453385K110137ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URINJFY2011-08-10
182431020443476K103788PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENTCFR2011-11-08
182431207637152K092570ABX PENTRA TPU CAL, MODEL A11A01898JIT2009-10-16
182432031874606K092116EASYCELL CELL LOCATORJOY2010-05-12
182431668263339K081276ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/HCFR2008-09-12
182431979560665K073309ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENTLCP2008-10-17
182431508125628K072115ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/HCGX2007-11-30
182431035061562K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HCIC2007-04-26
182431621619939K070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPCDQ2007-10-12
182431097409690K062737CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCGS2007-06-12
182431292934578K062180ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CPJFJ2006-10-02
182432042993794K061511R&D CBC-3D + CRP HEMATOLOGY CONTROLJPK2006-07-10
182431341219266K061138ABX PENTRA 400 : CRPDCK2006-09-29
182432032104051K060854ABX PENTRA 400: LIPOPROTEINSJIT2006-08-24
182431764817770K060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICALCIX2007-06-05
182431100255384K060325ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA PCIG2006-08-16
182431547173671K060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCIT2006-08-08
182431582324655K060205GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCJE2006-07-21
182431075454047K053308ABX MICROS CRP 200, OPTION IMGKZ2005-12-29
182431983684257K052007ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)CFR2005-12-16
182431289135157K050721ABX ERYTROLJPK2005-06-01
182431154262891K050719ABX PENTRA DX 120: OPTION SPS EVOLUTIONGKZ2005-04-26
182431274659310K030799MICROS 60GKZ2003-04-08
182431686223649K030291COULTER ACT 5DIFF AUTOLOADER (AL)GKZ2003-04-17
182431169703803K030144MODIFICATION TO PENTRA 60 AND PENTRA 60C+GKZ2003-01-31
182431300668101K024002PENTRA 80GKZ2003-01-03
182431663728813K022200PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120GKZ2002-07-29
182431881157483K003677ABX PENTRA 60C+ HEMATOLOGY ANALYZERGKZ2000-12-26
182431807298439K003534PENTRA 5DJPK2000-12-01
182431095176795K002646ABX MICROS CRPGKZ2000-10-26
182431119147969
182431651873958
182431015707733
182431109401262
182431114680889
182431184608420
182431192063257
182431347885105
182431349801686
182431356493371
182431416640486
182431417911341
182431420711919
182431434345118
182431475075657
182431539678883
182431542834281
182431545527078
182431554314372
182431571448409
182431681917126
182431706325932
182431746926674
182431811889145
182431822024749
182431834466127
182431838470012
182431894064920
182431895311577
182431913560808
182431960862498
182432023065309
182432024520622

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ142024-05-21
JPK52006-07-10
CFR32011-11-08
JFY22021-05-10
DCK22019-10-03
CJE22019-08-30
CJY22019-07-26
CGX22012-04-30
JIT22009-10-16
CZP12020-06-26
DBF12020-03-06
JJE12019-02-12
JJY12014-07-11
JOY12010-05-12
LCP12008-10-17
CDQ12007-10-12
CGS12007-06-12
CIX12007-06-05
CIC12007-04-26
JFJ12006-10-02
CIG12006-08-16
CIT12006-08-08
KRX11996-02-29

PMN#

GUDID#

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