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
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