FDA.reportPublic FDA data

HORIBA INSTRUMENTS INCORPORATED

Matched from indexed company URL: HORIBA LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18278211827821HORIBA INSTRUMENTS INCORPORATED1N2026-01-015449 Research Dr Canton MI US 48188
20867253002698356HORIBA INSTRUMENTS INCORPORATED1Y2026-01-019755 Research Dr IRVINE CA US 92618
20867253002698356HORIBA INSTRUMENTS INCORPORATED1Y2020-04-259755 Research Dr IRVINE CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2990241286342609K993853K-ASSAY MULTI-ANALYTE CALIBRATORJIX1999-12-27
2990241523746296K993537K-ASSAY TRANSFERRINDDG1999-11-30
2990241651792598K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
2990241817798355K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
2990241204038312K992002AUTOHDL CHOLESTEROL REAGENT SETLBR1999-08-05
2990241399209338K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
2990241655218319K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
2990241755677661K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
2990242057815437K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
2990241797621765K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
2990242051369372K983241ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYSJJY1998-09-29
2990241140604614K983130LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYSJJY1998-09-29
2990241541392331K982485SERAQUEST CMV IGMLFZ1999-01-13
2990241383242956K982281SERAQUEST RUBELLA IGMLFX1998-10-16
2990241874252791K981978AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATORMRR1998-07-22
2990241095257323K980907AXIS HOMOCYSTEINE ENZYME IMMUNOASSAYLPS1998-10-16
2990241930030682K973589LIQUID LDH-L REAGENT SETCFJ1997-10-08
2990241540749743K973588LIQUID ALKALINE PHOSHATASE REAGENT SETCJE1997-10-22
2990242008577228K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETJQB1997-10-10
2990241168330337K972725ALCOHOL REAGENT SETDIC1997-09-25
2990241978621003K972671BUN (LIQUID) REAGENT SETCDQ1997-07-20
2990241281338112K971672SERAQUEST TOXOPLASMA IGMLGD1997-10-21
2990241273670205K970781LIQUID GLUCOSE (OXIDASE) REAGENT SETCGA1997-04-21
2990241713485304K970560URIC ACID (LIQUID) REAGENT SETKNK1997-03-11
2990241477999053K963282SERAQUEST HSV IGGLGC1997-01-22
2990241852192660K961431LACTATE DEHYDROGENASE REAGENT SETCFJ1996-06-03
2990241449237836K961282GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60CFR1996-06-21
2990241325195437K961053SERAQUEST RUBELLA IGGLFX1996-09-04
2990241655333291K960092SERAQUEST TOXOPLASMA IGGLGD1996-06-17
2990241926629644K954191SERAQUEST CMV IGGLFZ1996-02-23
2990241271111186K954074AALTO SCIENTIFIC LIQUID CARDIAC CONTROLJJY1995-10-07
2990241354659142K951749BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3JJY1995-05-15
2990241114484299K942958CREATINE KINASE MB DETERMINATION (UV)JHW1994-11-21
2990241511534438K941287LIQUID ALT(SGPT) REAGENT SETCKA1994-05-03
2990241764930713K941132LIQUID AST (SGOT)REAGENT SETCIT1994-05-02
2990241044847828K940735LIQUID AMYLASE (CNPG3) REAGENT SETCIJ1994-08-01
2990241386524575K921625CALCIUM-ARSENAZO III REAGENT SETCIC1992-05-13
2990241062721338K920449POINTE 750 GLYCOMETERLCP1992-07-28
2990241525227664K910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDJIN1991-03-04
2990241534248404K897150LIPASE COLOR [TOYO] SERUM LIPASE TEST KITCHI1990-02-26
2990241948189887K891117HDL CHOLESTEROL REAGENTLBR1989-04-10
2990241013842577K882117ETHYL ALCOHOL STANDARDDNN1988-08-04
2990241131378769K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYJIY1987-01-21
2990241835968053K864706RAICHEM(TM) AMMONIA REAGENTJIF1987-01-05
2990241744892627K863832NAPHTHYL PHOSPHATE, ACID PHOSPHATASEJFH1986-12-16
2990241007407765K862033TRIGLYCERIDESCDT1986-07-22
2990241370051169K860572GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SETLCP1986-05-16
2990241157613923K860257DIRECT BILIRUBINCIG1986-02-21
2990242066065796K860154BUN (ENZYMATIC BERTHELOT) REAGENT SETCDL1986-02-06
2990241427990322K853592MAGNESIUMJGJ1985-09-16
2990241643303498K851432HEMOGLOBINKHG1985-07-12
2990241080118357K832870DIAZO COLORIMETRY, BILLIRUBINCIG1983-09-26
2990241645471721K831863CHOLESTEROL-ENZYMATIC REAGENT SETCHH1983-07-22
2990241639306290K831526URINE TOTAL PROTEIN CONTROLJJW1983-08-12
2990241954267406K830556CREATININECGX1983-03-24
2990241841848653K822471PSI ALBUMIN REAGENTCIX1982-09-14
2990242036903842K822470PSI INORGANIC PHOSPHORUSCEO1982-09-14
2990241878217097K822469PSI CALCIUM REAGENTCIC1982-09-14
2990241396356242K822468PSI TOTAL PROTEIN REAGENTCEK1982-09-14
2990241785869999K812574HDL CHOLESTEROL REAGENTLBR1981-09-24
2990242058729154K812452ALKALINE PHOSPHATASECJE1981-09-09
2990241982764528K812430URIC ACID REAGENT SETKNK1981-09-09
2990241345523778K812341UREA NITROGEN (BUN)CDQ1981-09-01
2990241102231888K810680ENZYMATIC TRIGLYCERIDECDT1981-03-31
2990241320735387K810674GLUCOSE OXIDASECGA1981-03-31
2990241805431227K810673ENZYMATIC CHOLESTEROLCHH1981-03-31
2990242003693651K800780SANDARE LYOPHILIZED HEMOGLOBIN CONTROLSJPK1980-04-24
2990241809311044K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)DHR2020-05-20
2990242010286454K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayDIO2020-03-12
2990241392457476K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetCGS2020-08-11
2990241836465220K181159LZI Fentanyl Enzyme ImmunoassayDJG2018-12-03
2990241383523741K180074Diazyme Lipoprotein (a) AssayDFC2018-03-22
2990241856861007K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS2018-02-27
2990241707693577K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry AnalyzerJGS2016-06-09
2990241292288593K141055LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)DJG2014-06-13
2990241304725999K140690BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERCDQ2014-09-02
2990241522831826K133710LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLSDKB2014-02-21
2990241339591971K132711CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENTLBS2014-05-08
2990241768815659K131556DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SETJIT2013-06-26
2990241388172038K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORDBF2012-05-24
2990241566531423K120763LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLSDJG2012-06-01
2990241858358843K120761LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLSDJG2012-05-08
2990241456555679K113661LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLAF2012-01-23
2990241628732550K113139LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLSDIO2011-11-22
2990241971417777K110298OPIATE ENZYME IMMUNOASSAYDJG2011-07-15
2990241059696142K110239LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLLDJ2011-06-23
2990241020608793K102210LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLSDKZ2010-12-28
2990241745992793K1011956-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLSDJG2010-07-06
2990241257427209K090844BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLSDJG2009-07-30
2990241248578472K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100LPS2009-07-31
2990241603300281K072018BS-200 CHEMISTRY ANALYZER, MODE BS-200CFR2008-02-01
2990241604670524K071388GENTIAN CYSTATIN C IMMUNOASSAYNDY2007-11-06
2990241150032927K070757MICROPROTEIN REAGENT SETJGP2007-12-04
2990241303004849K070504AMMONIA/ALCOHOL CONTROL SETJJY2007-04-11
2990242028465589K070251CARBON DIOXIDE LIQUID STABLE REAGENTKHS2007-04-30
2990241081789543K070207MULTI-ANALYTE CHEMISTRY CALIBRATORJIX2007-04-13
2990241557271039K052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETJIT2005-11-09
2990241577451057K050283CREATININE LIQUICOLORJFY2005-06-30
2990242041501694K042318AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SETJJY2004-12-09
2990241741891820K040391TOTAL BILIRUBIN REAGENT SETCIG2004-06-02
2990241258722149K033094ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)DKZ2003-12-19
2990241931912303K032764BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)DIS2003-11-03
2990241775456035K032461ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221DIC2003-10-03
2990241286358152K032365BENZODIAZEPINE ENZYME IMMUNOASSAYJXM2003-09-05
2990241631252820K031797METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)DJR2003-10-10
2990241516016289K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
2990241782369257K024006G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASEJBF2003-03-31
2990241846322641K023860MICROALBUMIN REAGENT SET AND CALIBRATORSDDZ2003-04-28
2990241302858599K023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBRDCK2003-02-04
2990241725399898K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)JXN2003-01-21
2990241816317134K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)CIJ2002-12-23
2990241467520846K023317METHADONE ENZYME IMMUNOASSAYDJR2002-12-12
2990242013171915K023316SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDLJ2002-12-16
2990241305442343K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117DRR2002-12-19
2990242070879399K020769SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDLJ2002-04-03
2990241572555659K020763COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)DIO2002-05-10
2990241567322748K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300CEC2002-04-05
2990241992105809K020395AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)DKZ2002-06-04
2990241982292600K020254PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011LCM2002-05-10
2990241817444968K013698AST (SGOT)CIT2001-12-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG72018-12-03
JJY62007-04-11
CDQ42014-09-02
DIO32020-03-12
DKZ32010-12-28
CIG32004-06-02
LCP32003-08-06
LBR31999-08-05
JGS22018-02-27
JIT22013-06-26
DBF22012-05-24
LPS22009-07-31
CFR22008-02-01
KHS22007-04-30
JIX22007-04-13
DJR22003-10-10
DIC22003-10-03
DCK22003-02-04
CIJ22002-12-23
DLJ22002-12-16
CIT22001-12-21
JLW21999-06-22
LFZ21999-01-13
LFX21998-10-16
CJE21997-10-22
LGD21997-10-21
CFJ21997-10-08
CGA21997-04-21
KNK21997-03-11
CIC21992-05-13
CDT21986-07-22
CHH21983-07-22
CGS12020-08-11
DHR12020-05-20
QBK12018-04-20
DFC12018-03-22
LBS12014-05-08
DKB12014-02-21
LAF12012-01-23
LDJ12011-06-23

PMN#

42 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next