Data / Medical devices / United States / Chemtron Biotech, Inc.
Chemtron Biotech, Inc.: FDA-registered device maker in San Diego, CA, United States, 5 510(k) clearances
Chemtron Biotech, Inc. is registered with the FDA (registration 3008852306) in San Diego, CA, United States. It lists 24 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008852306
- Address
- 9245 Brown Deer Rd Ste B, San Diego, CA, United States, 92121
- Owner or operator
- Chemtron Biotech, Inc. (10035407)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- July 14, 2015
- Registered through
- 2026
- Brand names listed
- Chemtrue, Chemtrue Drug Screen Cup Tests, Chemtrue Multi-Panel Drug Screen Tests, Chemtrue hCG Pregnancy Urine Test, Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Dip Card Tests and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Component, Cast | LGF | 1 | Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Amphetamine | DKZ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Barbiturate | DIS | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Benzodiazepine | JXM | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Methadone | DJR | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Opiates | DJG | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Phencyclidine | LCM | U | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Propoxyphene | JXN | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gas Chromatography, Methamphetamine | LAF | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Amphetamine, Employment And Insurance Testing, Exempt | PUX | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | PUY | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | PUZ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | PVA | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Methadone, Employment And Insurance Testing, Exempt | PVE | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Morphine, Employment And Insurance Testing, Exempt | PVG | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Test, Opiates, Employment And Insurance Testing, Exempt | PVH | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Thin Layer Chromatography, Methamphetamine | DJC | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Thin Layer Chromatography, Morphine | DNK | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2023 | K232736 | Chemtrue® 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 Test | DJG | Substantially Equivalent | Chemtron Biotech, Inc. | accessdata.fda.gov |
| April 18, 2016 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests | DJG | Substantially Equivalent | Chemtron Biotech, Inc. | accessdata.fda.gov |
| April 17, 2015 | K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | DJG | Substantially Equivalent | Chemtron Biotech, Inc. | accessdata.fda.gov |
| October 9, 2014 | K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests | DJG | Substantially Equivalent | Chemtron Biotech, Inc. | accessdata.fda.gov |
| July 26, 2013 | K131931 | CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST | LCX | Substantially Equivalent | Chemtron Biotech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Enzyme Immunoassay, Benzodiazepine
- All makers of Thin Layer Chromatography, Morphine
- All makers of Enzyme Immunoassay, Amphetamine
- All makers of Thin Layer Chromatography, Methamphetamine
- All makers of Gas Chromatography, Methamphetamine
Updated December 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.