Chemtron Biotech Inc

FDA Filings

This page includes the latest FDA filings for Chemtron Biotech Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Chemtron Biotech Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3008955915
FEI Number3008955915
NameEllen Q Meng
Owner & OperatorChemtron Biotech, Inc.
Contact Address9245 Brown Deer Road
San Diego CA 92121 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9245 BROWN DEER RD STE B CHEMTRON BIOTECH, INC
San Diego, CA 92121 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3008852306
FEI Number3008852306
NameChemtron Biotech, Inc.
Owner & OperatorChemtron Biotech, Inc.
Contact Address9245 Brown Deer Road
San Diego CA 92121 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address9245 Brown Deer Rd Ste B
San Diego, CA 92121 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
CHEMTRON BIOTECH INC
Generic 2024-08-06
CHEMTRON BIOTECH INC
DrugSmart Cup 2024-08-06
CHEMTRON BIOTECH INC
Premier Biotech PCU-13FCW-252024-06-05
CHEMTRON BIOTECH INC
Premier Biotech PCU-10FCW-252024-06-05
CHEMTRON BIOTECH INC
Generic 711A32-G2024-06-05
CHEMTRON BIOTECH INC
Generic 2024-04-17
CHEMTRON BIOTECH INC
Premier Biotech PCU-14FCW-252024-04-16
CHEMTRON BIOTECH INC
Generic 2024-04-16
CHEMTRON BIOTECH INC
Generic 2024-02-13
CHEMTRON BIOTECH INC
Generic 2024-02-13
CHEMTRON BIOTECH INC
DrugSmart Cup 2024-02-09
CHEMTRON BIOTECH INC
Generic 2024-02-09
CHEMTRON BIOTECH INC
Generic 711A31-G2024-02-09
CHEMTRON BIOTECH INC
Chemtrue 711A31-CT2024-02-09
CHEMTRON BIOTECH INC
DrugSmart Dip 30500D2023-05-05
CHEMTRON BIOTECH INC
DrugSmart Cup 10 2023-03-31
CHEMTRON BIOTECH INC
DrugSmart Cup 7 2023-03-31
CHEMTRON BIOTECH INC
DrugSmart Cup 9 2022-07-28
CHEMTRON BIOTECH INC
Premier Biotech 2022-06-01
CHEMTRON BIOTECH INC
Premier Biotech 2022-04-26
CHEMTRON BIOTECH INC
Premier Biotech 2022-04-22
CHEMTRON BIOTECH INC
Chemtrue 2021-12-14
CHEMTRON BIOTECH INC
OSTS 2021-07-07
CHEMTRON BIOTECH INC
Chemtrue 2021-07-05
CHEMTRON BIOTECH INC
Premier Biotech 2021-07-05
CHEMTRON BIOTECH INC
Chemtrue 2021-06-16
CHEMTRON BIOTECH INC
Generic 2021-05-28
CHEMTRON BIOTECH INC
Premier Biotech 2021-05-12
CHEMTRON BIOTECH INC
Premier Biotech 2021-05-11
CHEMTRON BIOTECH INC
Chemtrue 2021-05-11
CHEMTRON BIOTECH INC
Premier Biotech 2021-05-11
Chemtron Biotech, Inc.
Chemtrue Rapid COVID-19 IgM/IgG Antibody Screen Test2020-04-03
Chemtron Biotech, Inc.
OralTox2020-03-03
Chemtron Biotech, Inc.
OralTox2020-03-03
Chemtron Biotech, Inc.
OralTox2020-03-03
Chemtron Biotech, Inc.
OralTox2020-03-03
Chemtron Biotech, Inc.
OralTox2020-03-03
Chemtron Biotech, Inc.
OralTox2020-03-03
Chemtron Biotech, Inc.
OralTox2020-03-03
CHEMTRON BIOTECH INC
Generic 2020-02-19
CHEMTRON BIOTECH INC
Premier Biotech 2020-01-29
CHEMTRON BIOTECH INC
Generic 2020-01-23
CHEMTRON BIOTECH INC
Generic 2019-11-15
CHEMTRON BIOTECH INC
Generic 2019-11-15
CHEMTRON BIOTECH INC
Generic 2019-09-17
CHEMTRON BIOTECH INC
Generic 2019-09-17
CHEMTRON BIOTECH INC
Generic 2019-09-11
CHEMTRON BIOTECH INC
DrugSmart Dip 12 2019-08-19
CHEMTRON BIOTECH INC
Generic 2019-05-07
CHEMTRON BIOTECH INC
DrugSmart Cup 5 2019-03-28
CHEMTRON BIOTECH INC
Generic 2019-03-11
CHEMTRON BIOTECH INC
Generic 2019-03-08
CHEMTRON BIOTECH INC
DrugSmart Dip 7 2019-03-04
CHEMTRON BIOTECH INC
DrugSmart Cup 11 2019-01-14
CHEMTRON BIOTECH INC
Generic 2018-11-26
CHEMTRON BIOTECH INC
Generic 2018-10-11
CHEMTRON BIOTECH INC
Generic 2018-09-28
CHEMTRON BIOTECH INC
Generic 2018-09-10
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Chemtrue 2018-07-20
CHEMTRON BIOTECH INC
Chemtrue 2018-07-20
CHEMTRON BIOTECH INC
OSTS 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Generic 2018-07-20
CHEMTRON BIOTECH INC
Chemtrue 711E03CT2018-07-06
CHEMTRON BIOTECH INC
N/A 711E032018-07-06
CHEMTRON BIOTECH INC
N/A 711D012018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711C02CT2018-07-06
CHEMTRON BIOTECH INC
N/A 711C022018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711B01CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A15CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A10CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A09CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A08CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A07CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A06CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A05CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A03CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A02CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A01CT2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 711A13CT2018-07-06
CHEMTRON BIOTECH INC
N/A 711A132018-07-06
CHEMTRON BIOTECH INC
DrugSmart Cup 61060D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Cup 60620D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Cup 60500D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Dip 30723D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Dip 30620D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Dip 30600D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Dip 30530D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Dip 30510D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Dip 30450D2018-07-06
CHEMTRON BIOTECH INC
DrugSmart Dip 30180D2018-07-06
CHEMTRON BIOTECH INC
N/A 712F012018-07-06
CHEMTRON BIOTECH INC
OSTS 711L02OS2018-07-06
CHEMTRON BIOTECH INC
Chemtrue 712L01CT2018-07-06
CHEMTRON BIOTECH INC
OSTS 712L01OS2018-07-06
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Dip2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
DrugSmart Cup2016-12-07
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2016-12-07
Chemtron Biotech, Inc.
DrugSmart Dip2016-12-07
Chemtron Biotech, Inc.
DrugSmart Cup2016-12-07
Chemtron Biotech, Inc.
Chemtrue2016-12-07
Chemtron Biotech, Inc.
Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup With OPI 2000 Tests2016-04-18
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Multi-Panel Drug Screen Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue Multi-Panel Drug Screen Tests2015-07-14
Chemtron Biotech, Inc.
Chemtrue hCG Pregnancy Urine Test2015-07-14
Chemtron Biotech, Inc.
Chemtrue Drug Screen Cup Tests And Chemtrue Drug Screen Cup Tests With OPI 20002015-04-17
CHEMTRON BIOTECH, INC.
Chemtrue Multi-Panel DOA DIP Card Tests2014-12-01
Chemtron Biotech, Inc.
Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests2014-10-09
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
Chemtron Biotech, Inc.
Chemtrue2014-06-23
CHEMTRON BIOTECH, INC.
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST2013-07-26
CHEMTRON BIOTECH, INC.
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST2013-05-30
CHEMTRON BIOTECH, INC.
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS2012-11-29
CHEMTRON BIOTECH, INC.
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS2012-05-17
CHEMTRON BIOTECH, INC.
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD2011-09-14
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2011-02-24
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2011-02-24
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2011-02-24
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2011-02-24
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2011-02-24
Ellen Q Meng [Chemtron Biotech, Inc.]
Chemtrue2011-02-24
CHEMTRON BIOTECH, INC.
CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS2011-01-20

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020051655130Shanghai ,China (Mainland) -> Long Beach, CaliforniaURINE CUP PLASTIC CARD PLASTIC LABEL WHITE BO X498 CTN
2019112740042Shanghai ,China (Mainland) -> Long Beach, CaliforniaURINE CUP PLASTIC CARD777 CTN
2019090945611Shanghai ,China (Mainland) -> Long Beach, CaliforniaPLASTIC CARD, BAG, LABEL63 CTN
2018122958641Shanghai ,China (Mainland) -> Long Beach, CaliforniaURINE CUP PLASTIC CARD733 CTN
2018062210276Shanghai ,China (Mainland) -> Long Beach, CaliforniaPLASTIC CARD URINE CUP PLASTIC BAG657 CTN
2018060823829Shanghai ,China (Mainland) -> Long Beach, CaliforniaPLASTIC CARD URINE CUP PLASTIC BAG657 CTN
2018051229920Shanghai ,China (Mainland) -> Long Beach, CaliforniaPLASTIC ARTIELES PLASTIC BAG PLASTIC LABEL WHITE BOX626 CTN

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