FDA.reportPublic FDA data

CLINIQA CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20850641000135102CLINIQA CORPORATION1Y2026-01-01495 Enterprise Street San Marcos CA US 92078
30107258823010725882CLINIQA CORPORATION1N2026-01-01258 la Moree Rd San Marcos CA US 92078

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
55101593188193K982767RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATORJIX1998-09-21
55101482505855K982056RAICHEM CO2 REAGENTKHS1998-06-24
55101037238445K972853CHOLESTEROL RAPID LIQUID REAGENTCHH1997-09-24
55101407729879K963085LIQUID IMMUNOLOGY CONTROL LEVEL I, II, IIIJJX1996-08-20
55101747708692K958927
55101420245515K955691SERUM VOLATILES CONTROL LEVEL 1 & 2JJY1996-04-24
55101747916642K955690AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3JJY1996-04-24
55101631847375K953927LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEMDCF1995-09-15
55101082147484K953926LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEMDCK1995-09-15
55101801526989K923091KING DIAGNOSTICS GAMMA GT REAGENTJPZ1992-09-09
55101566458443K922969KING DIAGNOSTICS UREA NITROGEN REAGENTCDN1992-10-13
55102002663600K922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIJJX1992-07-30
55101527986805K912826WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2DKC1991-07-26
55101359265710K905085RAICHEM GGT REAGENTJQB1990-12-20
55101641159319K905084RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UVCGS1990-12-20
55101156655658K902593RAICHEM(TM) SPIA(TM) CRP REAGENTDCN1990-06-28
55101710253335K882726RAICHEM(TM) BILIRUBIN STANDARDJIS1988-08-29
55101548844841K874822RAICHEM(TM) MAGNESIUM REAGENTJGJ1988-01-21
55101669430859K872080RAICHEM(TM) SPIA(TM) APO B REAGENTSDFC1987-06-15
55101401292112K872079RAICHEM(TM) SPIA(TM) APO A-1 REAGENTSMSJ1987-06-15
55101563036567K864992RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)JFY1987-02-12
55101129446007K864819RAICHEM (TM)SERUM IRON AND TIBC REAGENTSJIY1987-02-12
55101232840789K864706RAICHEM(TM) AMMONIA REAGENTJIF1987-01-05
55101498883724K863620RAICHEM(TM) CHLORIDE REAGENTCHJ1986-09-26
55101332173886K862168RAICHEM CHOLINESTERASE REAGENTDIH1986-06-27
55101822452879K861718AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109JFJ1986-05-29
55101871279894K861269RAICHEM AMYLASE REAGENTJFJ1986-05-29
55101317042415K854544RAICHEM CO2 REAGENTKHS1985-12-13
55101154516037K844316RAICHEM PHOSPHORUS REAGENTCEO1985-01-03
55101193883067K842029TRIGLYCERIDES-GPO REAGENTCDT1984-07-09
55101923434506K841892RAICHEM BILIRUBIN REAGENT TOTAL/DIRECTCIG1984-06-07
55101820462420K840872RAICHEM CREATININE REAGENTCGX1984-04-18
55101603894306K832463RAICHEM ALKALINE PHOSPHATASE REAGENTCJE1983-09-12
55101893844469K831419RAICHEM LDH-P REAGENT W/SEPARATE START-CFJ1983-06-16
55101600499619K830207RAICHEM HDL-CHOLESTEROL REAGENTLBR1983-03-21
55101589116124K822312RAICHEM LDH-L REAGENTCFJ1982-08-27
55101171519551K820644RAICHEM TM CREATINE KINASE REAGENTCGS1982-04-01
55101274647838K820525RAICHEM GPT (ALT) REAGENTCKA1982-03-15
55101254145896K820270RAICHEM GOT (AST) REAGENTCIT1982-02-18
55101155241352K812641URIC ACID REAGENT-ENZYMATIC-COLOR-520 NMKNK1981-10-02
55101116975937K803287CHOLESTEROL REAGENT ENZYMATICCHH1981-01-16
55101373607223K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LEJJX2012-05-18
55101415825332K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2GGN2013-05-31
55101199759298K110534RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3JJY2012-01-23
55101984003502K083554CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3JJY2009-04-21
55101300652190K082107CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2JJY2008-09-17
55101392144065K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2JJW2009-01-16
55102067251186K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIACJJY2008-06-02
55101342822097K070741CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3JJY2007-05-04
55101058613068K062916CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3JJY2006-10-23
55101116818247K061182CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIBJJY2006-05-25
55101384030829K060570HEMOGLOBIN ALC CONTROLJJX2006-04-13
55101879918066K060322CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYEDJIT2006-03-21
55101205034588K052679CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-EJJX2005-11-18
55101800072595K043264LDL-EX SEIKEN ASSAY KITMRR2005-01-26
55101684108812K041898CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMJJX2004-08-16
55101372879025K041090HDL-EX SEIKEN ASSAY KITLBS2004-10-29
55101990928394K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTCIC2004-06-25
55102057196597K040927LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERSJJX2004-05-17
55101508921060K040535LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMSJJY2004-03-29
55101225460794K040455LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMSJJX2004-03-05
55101228131827K040091LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMSJJY2004-02-23
55101042220597K033910OLYMPUS URINE CALIBRATORJIX2004-01-30
55101237544375K033162LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMSJJY2003-10-10
55101177766081K032074LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERSJJY2003-10-21
55101321316363K031921LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMSJJY2003-08-25
55101080359949K031577LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMSJJY2003-08-06
55101091884626K031575LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERSJJY2003-07-23
55101649902683K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
55102047469110K031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2JJY2003-06-16
55101215486104K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELJJT2003-03-21
55101243261947K030705CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVELJJY2003-03-26
55101368942298K030566LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERSJJY2003-03-13
55101209473290K030150LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMSJJY2003-01-28
55101366424279K030074LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMSJIX2003-01-21
55101906260243K023661LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMSJJY2002-12-06
55101980549275K023250LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGEJJY2002-10-17
55101067074694K022936LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGEJJY2002-10-02
55102004005670K022885LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGEJJY2002-10-02
55101592498089K022867LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGEJJY2002-10-02
55101668502455K022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENTMRR2002-09-17
55101793470390K022767RAICHEM LIPID CALIBRATORJIX2002-09-03
55101776797199K022758LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETERJJX2002-09-17
55102066326648K022491LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMSJJX2002-08-27
55101909073361K022232CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3JJX2002-08-01
55101452789536K022049MODIFICATION TO RAICHEM CALCIUM REAGENTCJY2002-07-19
55101883788781K021194RAICHEM CRP HIGH SENSITIVITY TEST SYSTEMDCK2002-07-29
55101414557659K013332LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGEJJY2001-11-20
55101946268831K012668RAICHEM GLUCOSE UV REAGENTCFR2001-10-15
55101868023635K012649RAICHEM BUN RATE REAGENTCDQ2001-10-15
55101039649571K011169HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3JJY2001-05-18
1674451081501166
1674451163884071
55101250612637
55101335036479
55101370197892
1674451489046704
55101601992183
55101741542247
55101753377515
55101783359241
55101811026664
55101886717133
55101946018710

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY272012-01-23
JJX112012-05-18
JIX42004-01-30
MRR22005-01-26
DCK22002-07-29
KHS21998-06-24
CHH21997-09-24
CGS21990-12-20
JFJ21986-05-29
CFJ21983-06-16
GGN12013-05-31
JJW12009-01-16
JIT12006-03-21
LBS12004-10-29
CIC12004-06-25
LCP12003-08-06
JJT12003-03-21
CJY12002-07-19
CFR12001-10-15
CDQ12001-10-15
DCF11995-09-15
CDN11992-10-13
JPZ11992-09-09
DKC11991-07-26
JQB11990-12-20
DCN11990-06-28
JIS11988-08-29
JGJ11988-01-21
DFC11987-06-15
MSJ11987-06-15
JFY11987-02-12
JIY11987-02-12
JIF11987-01-05
CHJ11986-09-26
DIH11986-06-27
CEO11985-01-03
CDT11984-07-09
CIG11984-06-07
CGX11984-04-18
CJE11983-09-12

PMN#

GUDID#

76 records. Showing 1-40. Next