FDA.report

PHC Corporation

Matched from indexed company URL: PHC CORPORATION

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96162633001229191PHC Corporation1N2026-01-011-1-1 Sakada, Oizumi-machi Ora-gun Gunma JP 370-0596
30041678843004167884PHC Corporation1N2026-01-01110 OAZA-INOSHIRI-AZA-NISHIUENO WAKIMACHI MIMA Tokushima JP 779-3603
30143530453014353045PHC Corporation1N2026-01-0115F DAI-ICHI LIFE HIBIYA FIRST 1-13-2 Yurakucho Chiyoda-ku Tokyo JP 100-8403
30299731073029973107PHC Corporation1N2026-01-011460-6 Aza-Mitodai, Mito Tako-machi Katori-gun Chiba JP 2892247
14244933002905183PHC Corporation of North America1Y2020-04-251300 N Michael Dr Wood Dale IL US 60191

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2828191348535563P160017MiniMed 670G SystemOZP2016-09-28
2828191339476361P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
3225092007394717K231974PATHFAST®hs-cTnI-IIMMI2024-03-20
2828192007394717K231974PATHFAST®hs-cTnI-IIMMI2024-03-20
2828191458120796K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring SystemNBW2019-11-08
2828191290971780K170983NIOX VEROMXA2017-11-22
2828191907083385K162336Contour Next EZ Blood Glucose Monitoring SystemNBW2017-01-12
2828191325165107K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW2016-11-17
2828191738971663K150233NIOX VERO Airway Inflammation MonitorMXA2015-02-26
2828191956011580K133898NIOX VERO AIRWAY INFLAMMATION MONITORMXA2014-11-06
2828191210735036K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBW2014-06-23
210531067462821K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORNBW2013-09-26
2828191507758627K121190CONTOUR NEXT BLOOD GLUCOSE METERLFR2012-07-26
2828192004272774K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMLFR2012-03-06
210531352926715K110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERLFR2012-03-28
3225091946948066K100130PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2MMI2011-05-16
2828191946948066K100130PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2MMI2011-05-16
3225091335012168K083412PATHFAST HSCRPDCN2009-03-09
2828191335012168K083412PATHFAST HSCRPDCN2009-03-09
2828191898051340K081360PATHFAST CK-MB-II, PATHFAST MYO-IIJHX2009-08-17
3225091898051340K081360PATHFAST CK-MB-II, PATHFAST MYO-IIJHX2009-08-17
2828191992291017K072288PATHFAST D-DIMERGHH2009-05-06
3225091992291017K072288PATHFAST D-DIMERGHH2009-05-06
2828191713928158K072189PATHFAST NTPROBNP AND D-DIMER TESTSNBC2008-02-05
3225091713928158K072189PATHFAST NTPROBNP AND D-DIMER TESTSNBC2008-02-05
2828191710531187K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080NBW2006-09-11
1401921586777350K013703SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175MMQG2001-12-14
2105310170455821969-12-31
2105310170455821969-12-31
2105310170455821969-12-31
2105310170455821969-12-31
14019211636603231969-12-31
14019211636603231969-12-31
14019211636603231969-12-31
14019211636603231969-12-31
2828191053560754
210531053560754
210531210735036
2828191286490374
210531286490374
210531290971780
210531325165107
210531339476361
210531348535563
210531365464794
2828191365464794
210531507758627
2828191690216506
3225091690216506
210531738971663
210531907083385
210531956011580
1401921962068537
2828191962068537

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NBW62019-11-08
MMI42024-03-20
MXA32017-11-22
LFR32012-07-26
JHX22009-08-17
GHH22009-05-06
DCN22009-03-09
NBC22008-02-05
OZP12016-09-28
OZO12016-08-10
MQG12001-12-14

PMA

PMN

Applications

GUDID

PHCbi

2020-04-09

PHC CORPORATION

PHCbi

2019-11-15

PHC CORPORATION

PHCbi

2018-04-25

PHC CORPORATION

PHCbi

2018-04-25

PHC CORPORATION

PHCbi

2018-04-25

PHC CORPORATION

PHCbi

2018-04-25

PHC CORPORATION

PHCbi

2018-04-25

PHC CORPORATION