FDA.reportPublic FDA data

Yosuke Yamamoto

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96169363002671736Yosuke Yamamoto1N2026-01-018260 NW 27th Street, Suite 403 Miami FL US 33122
30034227263003422726Yosuke Yamamoto1N2026-01-018260 NW 27th Street, Suite 403 Miami FL US 33122
30134727433013472743Yosuke Yamamoto1N2026-01-018260 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
105291412795006K980908LACTATE PRO SYSTEMKHP1998-09-11
179381222937404K242209UASure II Blood Uric Acid Monitoring SystemPTC2025-04-04
105291043539879K232416AUTION EYE AI-4510 Urine Particle Analysis SystemLKM2024-05-03
105291694283926K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL2022-10-17
2041461822086584K221175Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL2022-10-17
179381064304457K220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemNBW2022-11-04
179381535542764K213887GAL-1A Plus Blood Glucose Monitoring SystemNBW2022-03-29
179381822180496K212140GlucoSure Link Blood Glucose Monitoring SystemNBW2022-08-25
179381732601378K201880MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBW2021-10-15
2041461512607645K200788Assure Titanium Blood Glucose Monitoring SystemPZI2022-05-23
105291953779755K193514AUTION MAX AX-4060 Urinalysis SystemJIL2023-04-13
179381872608700K182593KET-1 Blood Ketone Monitoring SystemJIN2018-12-18
105291746403176K170064GLUCOCARD W Blood Glucose Monitoring SystemNBW2017-08-16
105292031694356K162822ADAMS A1c HA-8180V, CALIBRATOR 80PDJ2017-06-29
179381316694697K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemNBW2016-12-23
105291620191276K160062AUTION ELEVEN Semi-Automated Urinalysis SystemJIL2016-10-07
2041462070121435K142336GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring SystemCGA2014-09-17
2041461652130358K142035GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEMNBW2014-09-05
105292001029771K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLKQO2013-02-01
2041461786837581K120759CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTIONCGA2012-06-05
179381642397922K120649AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEMNBW2012-07-06
179381329569465K120448MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROLCGA2012-04-06
179381064952973K113547GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GALCGA2012-03-28
179381943019324K113208GAL-1A BLOOD GLUCOSE MONITORING SYSTEMCGA2012-01-26
179381596105561K113098AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS IIINBW2012-01-17
179382028022805K110571TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USENBW2011-07-28
179382068047425K102816GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPSNBW2011-09-15
179381967649155K102481AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPNBW2011-04-28
179381707420269K102037AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPSCGA2010-08-13
179381132562416K101204MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTIONCGA2011-08-31
179381682437469K100747CONTREX PLUS LOW CONTROL SOLUTIONJJX2010-04-14
105291734320881K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMKQO2009-12-23
2041462010636070K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMCGA2009-11-24
2041461001785689K091102ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMSCGA2009-10-23
179381627679718K090043AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9CGA2009-04-09
105292068103172K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110CGA2008-10-21
179381764170598K073648GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1CGA2008-04-10
105292030727668K073416ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEMCGA2008-06-13
179381000024730K073137GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1NBW2008-04-01
179381645507500K070088ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEMNBW2007-02-16
179381729647046K062799GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEMCGA2007-02-06
105291165850451K053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSCIC2006-03-24
105291629098844K051648SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTSCGS2006-01-31
105291116720016K051432SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTSCIG2005-06-17
105291510844567K050790SPOTCHEM II LDH TESTCFH2005-06-06
105291111514405K050652SPOTCHEM II CREATININE, AMYLASE & ALP TESTSCGX2005-04-06
105291984754746K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSCIC2005-02-15
105291310964465K042443SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANELCHH2004-11-24
105291701712399K041427THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTSCGA2004-11-24
105291212193818K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERJJF2004-06-16
179381517101168K031843MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEMNBW2003-07-03
105291373822217K030600AUTION JET AJ-4270 URINE ANALYZERKQO2003-07-11
105291485842296K013783AUTION MAX AX-4280 URINALYSIS SYSTEMKQO2002-01-18
179381673559919K011233MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100CGA2001-05-18
179381295635617K002624GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEMCGA2001-01-22
179381266991933K002621GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEMCGA2001-01-22
179381349869705K002621GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEMCGA2001-01-22
179381188268813
105291310355521
2041461418969449
179381588302720
105291717919840
105291885413902
2041461037015396
179381197309236
105291248308981
105291344439273
2041461395617539
179381406162816
179381442300589
179381572745276
179381717638753
2041461786837581
2041461812009177
179382048435458

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CGA212014-09-17
NBW152022-11-04
KQO42013-02-01
JIL22023-04-13
QRL22022-10-17
CIC22006-03-24
PTC12025-04-04
LKM12024-05-03
PZI12022-05-23
JIN12018-12-18
PDJ12017-06-29
JJX12010-04-14
CGS12006-01-31
CIG12005-06-17
CFH12005-06-06
CGX12005-04-06
CHH12004-11-24
JJF12004-06-16
KHP11998-09-11