FDA.reportPublic FDA data

ARKRAY FACTORY USA, INC.

Matched from indexed company URL: ARKRAY FACTORY, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18328161832816ARKRAY FACTORY USA, INC.1Y2026-01-018260 NW 27th Street Suite 403 Miami FL US 33122

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105271208010457K972710QUANTIFY(901)JJW1997-08-15
105271043539879K232416AUTION EYE AI-4510 Urine Particle Analysis SystemLKM2024-05-03
105271720872416K230625ReliOn Premier BLU Blood Glucose Monitoring SystemNBW2023-08-10
105271793439056K223453Insulin SyringeFMF2023-03-02
105271391823303K222084OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet PreemieFMK2022-11-02
105271102785653K221970Lancing deviceQRL2022-08-30
105271694283926K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL2022-10-17
105271981237303K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)QRL2022-07-06
105271665352158K210065Verifine Safety Type Insulin Pen NeedleFMI2021-04-22
105272043990582K210059Promisemed Insulin Pen NeedleFMI2021-07-21
105271469439148K202682Promisemed Triple Safety Pen NeedleFMI2020-11-24
105271749821965K202681Promisemed Covered Safety Pen NeedleFMI2020-12-31
105271182825121K200788Assure Titanium Blood Glucose Monitoring SystemPZI2022-05-23
105271953779755K193514AUTION MAX AX-4060 Urinalysis SystemJIL2023-04-13
105271821357670K192220ReliOn Premier Classic Blood Glucose Monitoring SystemNBW2019-12-13
105271803067905K191853Dual-Safety Pen NeedleFMI2019-09-05
105271754003651K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS2019-02-21
105271502615381K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring SystemNBW2018-11-01
105271506168625K171982DROPLET PEN NEEDLEFMI2018-03-21
105271273801238K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring SystemNBW2017-10-19
105271746403176K170064GLUCOCARD W Blood Glucose Monitoring SystemNBW2017-08-16
105272031694356K162822ADAMS A1c HA-8180V, CALIBRATOR 80PDJ2017-06-29
105271457885034K162180Disposable Insulin SyringeFMF2016-12-29
105271142440492K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedleFMI2017-05-11
105271620191276K160062AUTION ELEVEN Semi-Automated Urinalysis SystemJIL2016-10-07
105271304842442K153537Sol-M Insulin Syringe, Sol-M TB SyringeFMF2016-06-17
105271031437459K151164Assure Prism multi Blood Glucose Monitoring SystemNBW2015-08-07
105271275755391K143437Droplet Pen NeedlesFMI2015-06-25
105271448442989K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring SystemCGA2014-09-17
105271889606129K142262AUTION CHECK PLUSJJW2015-04-10
105271912531238K142035GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEMNBW2014-09-05
105271375780860K141759OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERSMMK2014-10-24
105271952052423K132681SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGEMEG2014-05-22
105271080215669K130281OAK RIDGE PRODUCTS SHARP CONTAINERMMK2013-06-21
105271292823352K124021ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEMCGA2014-06-30
105272001029771K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLKQO2013-02-01
105271763665667K121133CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-10
105271334907831K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTIONCGA2012-06-05
105271630766703K120351CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CANBW2012-05-03
105271763835998K113098AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS IIINBW2012-01-17
105271709661067K112755ABACUS 5GKZ2012-03-27
105271399744657K111534ABACUS 3CPGKZ2012-08-02
105271641705879K110709ARK CARE DIABETES MANAGMENT SYSTEMNBW2011-05-19
105271663717747K103011ULTICARE SAFETY INSULIN SYRINGEMEG2011-02-02
105271259734516K093819ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)NBW2010-06-09
105271734320881K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMKQO2009-12-23
105271466259110K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMCGA2009-11-24
105271866396844K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMSCGA2009-10-23
105271719115104K090332ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001NBW2009-08-14
105271263468748K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)NBW2009-02-10
105272068103172K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110CGA2008-10-21
105272030727668K073416ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEMCGA2008-06-13
105272021214952K070088ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEMNBW2007-02-16
105271165850451K053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSCIC2006-03-24
105271629098844K051648SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTSCGS2006-01-31
105271116720016K051432SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTSCIG2005-06-17
105271510844567K050790SPOTCHEM II LDH TESTCFH2005-06-06
105271111514405K050652SPOTCHEM II CREATININE, AMYLASE & ALP TESTSCGX2005-04-06
105271984754746K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSCIC2005-02-15
105271310964465K042443SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANELCHH2004-11-24
105271340966382K041881ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100CGA2005-03-25
105271701712399K041427THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTSCGA2004-11-24
105271212193818K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERJJF2004-06-16
105271582000525K033851DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)JIL2004-03-02
105271373822217K030600AUTION JET AJ-4270 URINE ANALYZERKQO2003-07-11
105271485842296K013783AUTION MAX AX-4280 URINALYSIS SYSTEMKQO2002-01-18
105271497429461
105271717919840
105271885413902
105271092432340
105271248308981
105271342084490
105271344439273
105271521931170
105271645158488
105272059306361

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW152023-08-10
CGA92014-09-17
FMI82021-07-21
KQO42013-02-01
JIL32023-04-13
FMF32023-03-02
QRL32022-10-17
JJW22015-04-10
MMK22014-10-24
MEG22014-05-22
GKZ22012-08-02
CIC22006-03-24
LKM12024-05-03
FMK12022-11-02
PZI12022-05-23
GJS12019-02-21
PDJ12017-06-29
CGS12006-01-31
CIG12005-06-17
CFH12005-06-06
CGX12005-04-06
CHH12004-11-24
JJF12004-06-16

PMN#