FDA.reportPublic FDA data

Allen Chen

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Allen Chen5N2026-01-011521 Concord Pike Ste 201 Wilmington DE US 19803

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3521151900395073K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT2026-06-05
3521151992193828K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT2025-08-15
3521151244877242K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX2025-02-13
3521151434840740K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupNFT2025-02-07
3521151788494090K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamLCX2025-01-15
3521151597731754K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL2024-03-06
3521151573814978K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamLCX2024-02-05
3521151602742671K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJG2021-08-12
3521151853044156K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-08-20
3521151532267827K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-04-05
3521151617745982K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestNFT2017-05-02
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
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
3521152019433562K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripJHI2016-02-24
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
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
3521151119373913K122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTERLCX2013-03-14
3521151399472206K112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSJHI2012-07-17
3521151062687287
3521151086452931
3521151111779074
3521151150935480
3521151211781687
3521151240019553
3521151311640515
3521151346288099
3521151353560801
3521151357709109
3521151457669071
3521151501719674
3521151548402165
3521151602831813
3521151637887596
3521151731366701
3521151801929894
3521151820697252
3521151845828511
3521151888359724
3521151932674451
3521151948269332
3521151982693592
3521152012377235
3521152017494453
3521152058714534

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NFT52025-08-15
LCX42025-02-13
JHI22016-02-24
QYT12026-06-05
NGL12024-03-06
DJG12021-08-12
DJC12016-07-06
DKZ12016-03-31
DJR12015-10-05
DIS12015-06-04