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CHEMTRON

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088523063008852306Chemtron Biotech, Inc.1N2026-01-019245 Brown Deer Rd Ste B San Diego CA US 92121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1263721373421422K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card TestDJG2023-12-20
1263721983917363K181305OralTox Oral fluid Drug TestDJC2018-09-20
1263721486292301K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsDJG2016-04-18
1263721771598691K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000DJG2015-04-17
1263722028594283K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsDJG2014-10-09
1263721370920736K131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TESTLCX2013-07-26
1263721961113659K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TESTJHI2013-05-30
1263721795353578K123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSJXM2012-11-29
1263721365697016K121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTSDKZ2012-05-17
1263721758690804K111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARDJXM2011-09-14
1263721909434325
1263721290184531
1263721496808504
1263721686792203
1263721723806621
1263721757992916
1263721913696684
1263721924157711
1263722022278144
1263722060401838

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG42023-12-20
JXM22012-11-29
DJC12018-09-20
LCX12013-07-26
JHI12013-05-30
DKZ12012-05-17

PMN#

GUDID#

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