FDA.reportPublic FDA data

ASSURE TECH. (HANGZHOU) CO., LTD.

Matched from indexed company URL: Assure Tech., LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095855293009585529ASSURE TECH. (HANGZHOU) CO., LTD.1N2026-01-01Building 4, No. 1418-50, Moganshan Road, Gongshu District Hangzhou Zhejiang CN 310011
30306481603030648160ASSURE TECH LLC1Y2026-01-011521 Concord Pike Suite 201 Wilmington DE US 19803
30385602243038560224Assure Tech. (Hangzhou) Co., Ltd.1N2026-01-01No.128, Chunting Road, Fuyang District, Hangzhou, 311400 Zheji Hangzhou Zhejiang CN 311400

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3263441209071356K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT2026-06-05
1413611900395073K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT2026-06-05
3521151900395073K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT2026-06-05
3263441325860895K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT2025-08-15
1413611992193828K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT2025-08-15
3521151992193828K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT2025-08-15
1413611244877242K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX2025-02-13
3521151244877242K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX2025-02-13
3263441811149151K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX2025-02-13
3263441386689271K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupNFT2025-02-07
1413611434840740K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupNFT2025-02-07
3521151434840740K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupNFT2025-02-07
3263441684680754K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamLCX2025-01-15
1413611788494090K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamLCX2025-01-15
3521151788494090K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamLCX2025-01-15
3263441198980895K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL2024-03-06
1413611597731754K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL2024-03-06
3521151597731754K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL2024-03-06
1413611573814978K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamLCX2024-02-05
3521151573814978K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamLCX2024-02-05
3263441870980432K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamLCX2024-02-05
3263441187757096K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJG2021-08-12
1413611602742671K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJG2021-08-12
3521151602742671K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJG2021-08-12
3263441539111534K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-08-20
1413611853044156K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-08-20
3521151853044156K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-08-20
1413611346288099K181305OralTox Oral fluid Drug TestDJC2018-09-20
3263441246528556K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-04-05
1413611532267827K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-04-05
3521151532267827K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-04-05
1413611457669071K171403OralTox Oral Fluid Drug TestDJC2018-02-02
3263441558628198K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestNFT2017-05-02
1413611617745982K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestNFT2017-05-02
3521151617745982K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestNFT2017-05-02
1413611180613826K161044AssureTech 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
3521151180613826K161044AssureTech 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
3263442020213801K161044AssureTech 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
3263441587191466K153465AssureTech 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
1413611767298287K153465AssureTech 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
3521151767298287K153465AssureTech 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
3263441070128456K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripJHI2016-02-24
1413612019433562K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripJHI2016-02-24
3521152019433562K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripJHI2016-02-24
1413611251007606K152025AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)DJR2015-10-05
3521151251007606K152025AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)DJR2015-10-05
3263441735667234K152025AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)DJR2015-10-05
1413611089805510K151211AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split CupDIS2015-06-04
3521151089805510K151211AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split CupDIS2015-06-04
3263441677665878K151211AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split CupDIS2015-06-04
1413612017494453K142408FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)LDJ2014-09-25
1413611501719674K132834FASTEP S10 HCG SERUM/URINE COMBO TESTJHI2014-01-09
1413611119373913K122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTERLCX2013-03-14
3521151119373913K122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTERLCX2013-03-14
1413611062687287K121065POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICEDKZ2013-05-24
1413611399472206K112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSJHI2012-07-17
3521151399472206K112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSJHI2012-07-17
1413611353560801
1413611637887596
1413611801929894
1413612058714534
3263441026524914
1413611062687287
3521151062687287
1413611086452931
3521151086452931
3263441098090792
1413611111779074
3521151111779074
1413611150935480
3521151150935480
3263441183623968
3263441196121752
1413611211781687
3521151211781687
1413611240019553
3521151240019553
3263441241559085
3263441279452608
3263441279542559
1413611311640515
3521151311640515
3263441317129310
3263441328171390
1413611346288099
3521151346288099
3263441352764627
3521151353560801
1413611357709109
3521151357709109
3263441368534396
3263441405489748
3263441412471049
3263441453986560
1413611457669071
3521151457669071
1413611501719674
3521151501719674
1413611548402165
3521151548402165
1413611602831813
3521151602831813
3263441620133476
3263441634178118
3521151637887596
3263441674655347
1413611731366701
3521151731366701

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NFT182025-08-15
LCX122025-02-13
JHI82016-02-24
DJC62018-09-20
DKZ52016-03-31
DJR42015-10-05
DIS42015-06-04
QYT32026-06-05
NGL32024-03-06
DJG32021-08-12
LDJ12014-09-25

PMN#

GUDID#

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