FDA.reportPublic FDA data

EASY HEALTHCARE CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30127253633012725363EASY HEALTHCARE CORPORATION1Y2026-01-018251 Lemont Rd Darien IL US 60561

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1953331527203534K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamLCX2024-06-21
1953331118274942K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL2024-03-06
1953331840109872K240254Blood Pressure Monitor (TMB-2296-BT)DXN2024-05-31
1953331705682541K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamLCX2024-02-05
1953331815089161K233146Blood Pressure MonitorDXN2024-03-19
1953331750888095K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50LDJ2024-01-17
1953331284652826K231045Healgen URS Test StripsLJX2023-06-16
1953331899289142K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)LCX2023-02-28
1953331052065626K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test MidstreamLCX2022-04-05
1953331418012566K212705Actively Trying Personal Lubricant UnfragrancePEB2022-02-09
1953331347860291K212418hCG One Step Pregnancy TestLCX2022-06-30
1953331363146728K212248GlucoLeader Enhance 2 Blood Glucose Monitoring SystemNBW2022-08-29
1953331818596637K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2022-01-05
1953331431389497K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFT2020-09-25
1953331220183516K200727TENS and Muscle StimulatorNUH2020-06-18
1953331906887487K200561StimPlus Patch, StimPlus Patch, StimPlus PatchNUH2020-07-01
1953331753676351K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test MidstreamLCX2019-11-22
1953331106119418K183393Digital ThermometerFLL2019-11-18
1953331392825406K182701Wondfo T-Cup Multi-Drug Urine Test CupNFT2018-12-03
1953331071029722K182495Electronic Blood Pressure MonitorDXN2019-03-03
1953331096722916K182428GlucoLeader Enhance Blood Glucose Monitoring SystemNBW2019-05-08
1953331171435044K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-04-05
1953331189729837K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisJIN2017-07-06
1953331774820411K163518Digital ThermometerFLL2017-09-19
1953331179425696K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13NUH2017-04-14
1953331418829535K161560Fingertip Pulse Oximeter MD300CN310DQA2016-10-05
1953331913289131K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)DJC2016-07-06
1953331602897606K160308Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)FLL2016-07-15
1953331792329889K153520Electronic Pulse StimulatorNUH2016-05-05
1953331034227238K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)DKZ2016-03-31
1953331151345268K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36FLL2016-05-27
1953331077106006K153146Infrared Ear ThermometerFLL2016-03-31
1953331323096827K143268TENS AND POWERED MUSCLE STIMULATORNUH2015-07-21
1953331702588502K141260ELECTRONIC PULSE STIMULATORNUH2014-09-17
1953331517376303K140582FINGERTIP PULSE OXIMETERDQA2014-08-28
1953331177975070K133968WONDFO MULTI-DRUG URINE TEST CUP, PANELDKZ2014-02-25
1953331160395885K132588ADHESIVE ELECTRODESGXY2013-11-22
1953331781891987K131921ELECTRONIC PULSE STIMULATORNUH2013-11-15
1953331655770550K131457FETAL ULTRASONIC MONITOR AND ACCESSORIESKNG2014-01-24
1953331185943477K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
1953331932583662K130665WONDOFO MULTI-DRUG URINE TEST CUP / PANELDJG2013-04-09
1953331869561157K130231NON-CONTACT INFRARED THERMOMETERFLL2013-10-15
1953331971819238K123703HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)LCX2013-04-10
1953331737512948K123669TRANSTEK WRIST BLOOD PRESSURE MONITORDXN2012-12-21
1953331982891284K122912DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)FLL2012-11-07
1953331802314663K122482TRANSTEK WRIST BLOOD PRESSURE MONITORDXN2012-10-22
1953331935244581K121557WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TESTLDJ2012-07-25
1953332031281781K120058TRANSTEK BLOOD PRESSURE MONITORDXN2012-01-31
1953331769873852K110124FETAL DOPPLER JPD-100SKNG2011-02-04
1953332063849238K103574PREGNANCY ONE STEP RAPID TESTLCX2011-07-28
1953331692328264K101681TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995DXN2011-05-27
1953331792185271K101387DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CNFLL2010-08-03
1953331811293733K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQA2008-11-10
1953331827645314K082480CONTEC POCKET FETAL DOPPLERKNG2009-02-25
1953331133621372K072641DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.FLL2007-11-01
1953331587664678K063295ACON UTI URINARY TRACT INFECTION TEST STRIPSLJX2007-10-12
1953332038747881K061559ACON URINALYSIS REAGENT STRIPSCDM2006-08-11
1953331920621220K043443ONE STEP HCG URINE PREGNANCY TESTLCX2005-04-08
1953331037755518
1953331773454720
1953331858334757
1953331968372176
1953332031250079
1953331054505592
1953331085689774
1953331199420484
1953331226147729
1953331252047908
1953331335049990
1953331345880155
1953331469043417
1953331469137287
1953331505175841
1953331764344903
1953331822517725

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FLL152019-11-18
DXN132024-05-31
LCX122024-06-21
NUH122020-07-01
DQA62016-10-05
NFT42020-09-25
KNG42014-01-24
LDJ32024-01-17
LJX32023-06-16
DKZ32016-03-31
NBW22022-08-29
JIN22017-07-06
DJC22016-07-06
GXY22013-11-22
DJG22013-04-09
NGL12024-03-06
PEB12022-02-09
CDM12006-08-11

GUDID#

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