FDA.reportPublic FDA data

Carolina Liquid Chemistries Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20308613000215862Carolina Liquid Chemistries Corp.1Y2026-01-01510 W Central Ave Ste C Brea CA US 92821

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
529411383952349K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SETLCP1999-12-21
529411974585557K993354K-ASSAY APO BDER1999-10-28
529411758128521K993345K-ASSAY APO AIDER1999-10-25
529412068282069K991409K-ASSAY RHEUMATOID FACTORDHR1999-06-09
529411739739146K981978AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATORMRR1998-07-22
529411150734148K974833CK-NAC REAGENTCGS1998-02-13
529411315559266K973589LIQUID LDH-L REAGENT SETCFJ1997-10-08
529411775337739K971467SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)CFR1997-06-16
529411754562790K971309UREACDQ1997-08-01
529411278266695K971072CHOLESTEROL REAGENTCHH1997-06-20
529411706850009K970664GLUCOSE REAGENTCFR1997-08-01
529411446417500K965134ALT/SGPTCKA1997-02-18
529411885811695K965126AST/SGOTCIT1997-01-17
529411302320150K964914ALKALINE PHOSPHATASECJE1997-02-04
529411267061906K963116UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAYJMO1996-08-20
529411537940193K961179SENTINEL LIPASE LIQUID MODEL 17.401BCHI1996-07-19
529411888122102K960708BENZODIAZEPINE SERUM TOX EIA TESTJXM1996-05-20
529411891638044K960664BARBITURATE SERUM TOX EIA ASSAYDIS1996-05-06
529411609227093K960187COCAINE METABOLITE EIA TESTDIO1996-04-02
529411280799569K955936TOTAL PROTEIN REAGENTCEK1996-03-12
529411631170811K955928BARBITURATE EIA ESSAY (MODIFICATION)DIS1996-03-11
529411860762606K955781ALBUMINCIX1996-03-13
529411089344546K943998CANNABINOID EIA ASSAYLDJ1994-11-04
529411749183286K943414PROPOXPHENE EIA TESTJXN1994-09-09
529411433789110K935463CREATINE KINASE-MB (CK-MB) REAGENT SETCGS1994-01-11
529411336968244K935320PHENCYCLIDINE EIA ASSAYLCM1993-12-29
529411252934581K934891AMPHETAMINES EIA ASSAY MODIFICATIONDKZ1994-01-13
529411949368577K934667METHADONE ENZYME IMMUNOASSAYDJR1994-01-26
529411183404687K932888INTERSECT SYSTEMS DIRECT AMYLASE REAGENTJFJ1994-01-31
529411178018961K930529BENZODIAZEPINE ENZYME IMMUNOASSAYJXM1993-08-05
529411456827968K923783ETHYL ALCOHOL ASSAYDMT1993-01-21
529411519729949K870827INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENTCDT1987-03-13
529412055899400K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYJIY1987-01-21
529411649621643K220046Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11DJG2022-12-13
529411800514424K181159LZI Fentanyl Enzyme ImmunoassayDJG2018-12-03
529411944447490K180074Diazyme Lipoprotein (a) AssayDFC2018-03-22
529411589300637K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsDJR2017-06-26
529411820466332K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW2017-07-14
529411096699263K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine ControlsDJG2015-03-09
529411194818131K141406IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORSDJG2014-07-01
529411605795053K141055LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)DJG2014-06-13
529411034769809K140690BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZERCDQ2014-09-02
529411666576349K133519CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CARJJE2014-05-16
529411897499663K133410DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SETMRG2014-03-14
529411049751950K132711CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENTLBS2014-05-08
529411463696050K120763LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLSDJG2012-06-01
529411643953514K113661LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLAF2012-01-23
529411051842545K113139LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLSDIO2011-11-22
529411718939927K112377BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZERCFR2012-03-23
529412030116835K110298OPIATE ENZYME IMMUNOASSAYDJG2011-07-15
529411915031037K110239LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLLDJ2011-06-23
529411202731706K103656THERMO SCIENTIFIC MAS R DOA TOTALDIF2011-03-24
529411373043995K103531PRESTIGE 24I; BIOLIS 24I; MGC 240CFR2011-12-01
529411820219851K1011956-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLSDJG2010-07-06
529411379284603K093680DIAZYME CYSTATIN C ASSAYNDY2010-04-08
529411312315786K091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORDCF2010-04-29
529411811238866K090844BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLSDJG2009-07-30
529411152900630K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3JIX2009-06-05
529411601437392K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100LPS2009-07-31
529411848967080K082488DIAZYME LP(A) ASSAYDFC2009-01-13
529411804839271K071971DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CALLPS2007-09-17
529411057986222K070251CARBON DIOXIDE LIQUID STABLE REAGENTKHS2007-04-30
529411193810962K070207MULTI-ANALYTE CHEMISTRY CALIBRATORJIX2007-04-13
529411552541832K062105DIAZYME CREATININE LIQUID REAGENTS ASSAYJFY2007-04-23
529411333327301K050283CREATININE LIQUICOLORJFY2005-06-30
529412023756433K042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITJJX2004-10-29
529411664138811K040977GENCHEM ELECTROLYTE BUFFERJGS2004-12-27
529412065479481K040976GENCHEM CREATININE REAGENTCGX2004-12-27
529411484573144K040975GENCHEM CO2 ACID REAGENTJFL2004-12-27
529411161667162K040974GLUCOSE OXIDASE, GLUCOSECGA2004-12-27
529412036898143K040973BUN REAGENTCDS2004-12-27
529411239824684K040972CALCIUM, AZO DYE REAGENTCJY2004-12-27
529411754245282K040971GENCHEM ISE ELECTROLYTE REFERENCEJGS2004-12-22
529411793541135K040758MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECTDIF2004-05-28
529411112178302K040411DRI OXYCODONE ASSAYLAS2004-05-27
529411126177029K033094ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)DKZ2003-12-19
529411418936266K032764BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)DIS2003-11-03
529411324721012K032461ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221DIC2003-10-03
529411684065961K032365BENZODIAZEPINE ENZYME IMMUNOASSAYJXM2003-09-05
529411962757611K031797METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)DJR2003-10-10
529412032449703K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
529411014720114K030545CRP-LATEX (II)X2 SEIKEN ASSAY KITDCK2003-06-02
529411266542992K023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBRDCK2003-02-04
529411883031079K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)JXN2003-01-21
529411795705452K023617DRI METHADONE METABOLITE ENZYME IMMUNOASSAYDJR2003-08-27
529411757914010K023317METHADONE ENZYME IMMUNOASSAYDJR2002-12-12
529411669325531K021636ALBUMIN REAGENTCJW2002-07-17
529412024647598K020763COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)DIO2002-05-10
529411110644800K020395AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)DKZ2002-06-04
529411246031712K020254PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011LCM2002-05-10
529411383742377K012110DRI ECSTASY ENZYME IMMUNOASSAYDKZ2001-08-27
529411339288532K012038JAS URIC ACID LIQUID REAGENTKNK2001-08-21
529411979526366K011972DIRECT BILIRUBIN REAGENTCIG2001-08-27
529411128041148K011150DRIDAU OPIATE ASSAYDJG2001-06-20
529411740428430K003912PHOSPHORUS REAGENTCEO2001-02-21
529411071119716K003892TOTAL BILIRUBIN REAGENTCIG2001-02-20
529411548216365K003835JAS MAGNESIUM REAGENTJGJ2001-03-23
529411612098247K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SETDCK2000-10-13
529411059760660
529411817184790
529411947990197
529412056433919
529411006248954
529411148009053
529411163666408
529411341169669
529411416106159
529411424313175
529411490751081
529411566412067
529411847373471
529411921128922
529411951184995
529412048534029

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG102022-12-13
DJR52017-06-26
CFR42012-03-23
DKZ42003-12-19
DIO32011-11-22
DIS32003-11-03
JXM32003-09-05
DCK32003-06-02
DFC22018-03-22
CDQ22014-09-02
LDJ22011-06-23
DIF22011-03-24
LPS22009-07-31
JIX22009-06-05
JFY22007-04-23
JGS22004-12-27
LCP22003-08-06
JXN22003-01-21
LCM22002-05-10
CIG22001-08-27
DER21999-10-28
CGS21998-02-13
JLW12017-07-14
JJE12014-05-16
LBS12014-05-08
MRG12014-03-14
LAF12012-01-23
DCF12010-04-29
NDY12010-04-08
KHS12007-04-30
JFL12004-12-27
CJY12004-12-27
CGX12004-12-27
CGA12004-12-27
CDS12004-12-27
JJX12004-10-29
LAS12004-05-27
DIC12003-10-03
CJW12002-07-17
KNK12001-08-21

PMN#