CLINICO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10641303002684533CLINICAL DIAGNOSTIC SOLUTIONS, INC.1Y2026-01-011800 N.W. 65TH AVE. PLANTATION FL US 33313
15278261527826CLINICAL SUPPLY1Y2026-01-017082 Office Park Dr Liberty Township OH US 45069
15286571000136416CLINICAL TECHNOLOGY INC.1Y2026-01-017005 S Edgerton Rd Brecksville OH US 44141
17226841000220650CLINICAL INNOVATIONS, LLC1N2026-01-01747 W 4170 S MURRAY UT US 84123
19101441910144CLINICAL REFERENCE LABORATORY, INC.1N2026-01-018433 Quivira Rd Lenexa KS US 66215
20289161000142646CLINICOMP INTL., INC.1N2026-01-019655 Towne Centre Dr SAN DIEGO CA US 92121
20293021000306472CliniSys, Inc1N2026-01-013300 E. Sunrise Dr. TUCSON AZ US 85718
20850641000135102CLINIQA CORPORATION1Y2026-01-01495 Enterprise Street San Marcos CA US 92078
30036900123003690012CLINICAL MEDICAL SERVICES, INC.1Y2026-01-01Road PR-3 KM 9.5 65th Infantry Ave. Reparto Industrial San Gabriel Carolina PR US 00985
30037217473003721747CLINICAL HEALTH SERVICES1Y2026-01-015129 W Idlewild Ave Tampa FL US 33634
30044235843004423584CLINICAL COMPUTER SYSTEMS, INC.1Y2026-01-012895 Greenspoint Pkwy, Suite 650 Hoffman Est IL US 60169
30057272433005727243CLINICAL RESOLUTION LABORATORY, INC.1N2026-01-011530 Moonstone Brea CA US 92821
30064627713006462771Clinical Image Retrieval Systems, Inc.1N2026-01-0112 Cork Hill Rd., Bldg 2 Franklin NJ US 07416
30073389003007338900Clinical Choice LLC1Y2026-01-015574 Garden Village Way Suite D400 Greensboro NC US 27410
30088103573008810357Clinico Medical Sp. z o.o.1N2026-01-01Blonie k/ Wroclawia, ul. Roberta Kocha 1 Blonie/Miekinia Dolnoslaskie PL 55-330
30107258823010725882CLINIQA CORPORATION1N2026-01-01258 la Moree Rd San Marcos CA US 92078
30114893043008836669Clinical Medical Services, Inc1Y2026-01-01240 Sabanetas IND PK Ponce PR US 00716
30141957853014195785CLINISUPPLIES (NANJING) CO., LTD1N2026-01-0186-8 Shuanggao Road Gaochun Nanjing Jiangsu CN 211316
12258023001596579CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.1Y2020-04-25559B Federal Rd BROOKFIELD CT US 06804
24317882431788CLINIMED, INC1Y2020-04-251866 Leithsville Road Suite 230 Hellertown PA US 18055
30108142303010814230Clinical Diagnostics of Puerto Rico, LLC1Y2020-04-25B-2 Carr 887 Km 0.6 Bo Martin Gonzalez Carolina Commercial Park Carolina PR US 00987
30152598443015259844CLINICAL IMAGING SOLUTIONS1N2020-04-25316 Turner Lane Suite A West Chester PA US 19380

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00812137011848Albumin Reagent - For the quantitative determination of Albumin in serum.8004533328quality@cdsolinc.com
00812137011879AMYLASE (CNPG3) Reagent Set - For the quantitative kinetic determination of amylase activity in human serum using a manual or automated procedure. The determination of amylase activity in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.8004533328quality@cdsolinc.com
00815290013872CLINICAL HEALTH SERVICES, INC. - Ultrasound Lotion, Gallon with Dispenser813-871-3120jeff@clinicalhealthservices.com
00815290013896CLINICAL HEALTH SERVICES, INC. - Ultrasound Gel, CLEAR, 5Liter with Dispenser813-871-3120jeff@clinicalhealthservices.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
178411619451471K993375CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMERKRX1999-12-20
543201098862727K990108LC FLOWFILLEBF1999-03-09
543201050411254K984484LC MICROHYBRIDEBF1999-01-20
543201647052627K984097DC-COREEBF1999-02-09
55101593188193K982767RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATORJIX1998-09-21
55101482505855K982056RAICHEM CO2 REAGENTKHS1998-06-24
1261771914351659K981260KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MHDB1998-09-22
1261771812785744K974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERHFN1998-02-19
1036501643646944K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
543201802827821K973201PROVI CEMENTEMA1998-06-05
55101037238445K972853CHOLESTEROL RAPID LIQUID REAGENTCHH1997-09-24
1036501333225805K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEI1997-08-14
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
543201124295881K953504MICROPRIMEKLE1995-10-03
543201352368875K951075S & C VINYL POLYSILOXANE IMPRESSION MATERIALELW1995-03-31
1261771849363149K940681CLEARVIEW UTERINE MANIPULATORLKF1994-07-26
543201628131134K931867ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINEEBF1993-09-09
470941415684769K931133CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISPHGM1995-03-29
2256181177549004K926416SAT PAD(TM)LNH1993-05-19
55101801526989K923091KING DIAGNOSTICS GAMMA GT REAGENTJPZ1992-09-09
55101566458443K922969KING DIAGNOSTICS UREA NITROGEN REAGENTCDN1992-10-13
55102002663600K922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIJJX1992-07-30
543201674824189K921601ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINEJES1992-06-16
55101527986805K912826WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2DKC1991-07-26
1036502031811932K911505FIXATION WIREHTY1991-04-12
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
647781953832861K870692PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085HGM1987-05-04
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
1261771886192541K250897Koala Intrauterine Pressure Catheter (IPC-5000E)HFN2025-05-22
1261772057720920K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)HDB2025-10-08
1261771008689848K223900babyLance Safety Heelstick (BLM, BLN, BLP)FMK2023-02-24
1589411961927749K221121Volumat Polyethylene I.V. Administration SetFPA2023-06-16
1589411809783663K220301Volumat LineFPA2023-06-02
1589411377032239K212445freeflex+ Transfer AdapterLHI2022-06-01
1327181905385855K210327First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test CupQBF2021-08-12
1589411902906108K192368CATSmartCAC2019-09-27
1589411116719526K180831CATSmartCAC2018-12-10
1589411461767317K162826Encore NeutralFPA2017-06-15
1589411052083267K160735CATSmartCAC2016-09-16
1327181743067611K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2016-05-23
1261771169403250K153591ebb Complete Tamponade SystemOQY2016-01-14
1261772023666529K150558Eclipse SystemPJH2015-11-12
543201858911075K141838SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)GEX2014-07-25
1261771337062533K140163KOALA TOCOHFM2014-05-29
1261771739615571K131781CLEARVIEW TOTALLKF2014-05-28
1261771144374736K130132BABYLANCE HEEL INCISION DEVICEFMK2013-02-11
543201301276084K122039KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS BEBG2012-12-27
2163741451545236K122003RENEW INSERTPBP2012-10-26
1589411053905989K121613AGILIA INFUSION SYSTEMFRN2013-05-01
55101373607223K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LEJJX2012-05-18
647781926751365K121208OBIX PERINATAL DATA SYSTEM 7.0HGM2012-06-14
55101415825332K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2GGN2013-05-31
1036501403045333K120117CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEMKCT2012-04-16
1261771297314201K110605ROM PLUSNQM2011-11-23
55101199759298K110534RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3JJY2012-01-23
1036501014631893K100916MEDICON MOGEN CLAMPHFX2010-12-06
543201005780991K100752PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)KLE2010-07-16
1036501479895545K092544INSTRUMED VASCULAR CLAMPSDXC2009-10-26
543201258629474K092539SEAMFREEEBF2009-10-01
543201989910596K091894TEMPORARY C&B COMPOSITEEBG2009-07-23
55101984003502K083554CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3JJY2009-04-21
543201199100620K082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTEMA2009-01-15
55101300652190K082107CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2JJY2008-09-17
55101392144065K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2JJW2009-01-16
543201025752130K081120FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALSELW2008-05-01
543201847595681K081017TEMPLATE AND COUNTER-FITELW2008-08-04
55102067251186K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIACJJY2008-06-02
543201060526780K073005ELITE GLASSELW2007-12-12
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
1261771375879728K061539GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICEHFX2007-09-20
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
543201506339144K060335FILE-EZEKJJ2006-02-24
55101879918066K060322CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYEDJIT2006-03-21
543201768175779K053014POLY SILOXANE IMPRESSION MATERIALELW2005-11-15
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
1036501706590819K042608TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110GEI2004-10-18
55101684108812K041898CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMJJX2004-08-16
178411423189500K041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)KRZ2004-06-10
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
543201108670814K040769STRUCTUR 2 SCEBG2004-04-07
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY272012-01-23
JJX112012-05-18
ELW62008-08-04
EBF52009-10-01
HGM42012-06-14
JIX42004-01-30
FPA32023-06-16
CAC32019-09-27
EBG32012-12-27
HDB22025-10-08
HFN22025-05-22
FMK22023-02-24
LKF22014-05-28
HFX22010-12-06
KLE22010-07-16
EMA22009-01-15
MRR22005-01-26
GEI22004-10-18
DCK22002-07-29
KHS21998-06-24
CHH21997-09-24
CGS21990-12-20
JFJ21986-05-29
CFJ21983-06-16
LHI12022-06-01
QBF12021-08-12
PWB12017-07-27
JXM12016-05-23
OQY12016-01-14
PJH12015-11-12
GEX12014-07-25
HFM12014-05-29
GGN12013-05-31
FRN12013-05-01
PBP12012-10-26
KCT12012-04-16
NQM12011-11-23
DXC12009-10-26
JJW12009-01-16
JIT12006-03-21

NDC#

131 records. Showing 1-40. Next

PMA#

PMN#

200 records. Showing 1-40. Next

Applications#

GUDID#

120 records. Showing 1-40. Next