# Chemtron Biotech, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 11 (2011–2023): 11 510(k) clearances
- Product codes: DJG (4), DKZ (3), JXM (2), LCX (1), JHI (1)
- Predicates its devices cite: 18 (7 its own); citations of its devices by later devices: 19 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Innovacon, Inc.: 4 (https://510kreport.com/company/innovacon)
- Wyntek Diagnostics, Inc.: 2 (https://510kreport.com/company/wyntek-diagnostics)
- Varian, Inc.: 2 (https://510kreport.com/company/varian)
- Teco Diagnostics: 1 (https://510kreport.com/company/teco-diagnostics)
- Phamatech: 1 (https://510kreport.com/company/phamatech)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Firms that cite its devices most
- Assure Tech. (Hangzhou) Co, Ltd.: 3 (https://510kreport.com/company/assure-tech-hangzhou)
- Safecare Biotech (Hangzhou) Co., Ltd.: 2 (https://510kreport.com/company/safecare-biotech-hangzhou)
- Nantong Egens Biotech Co., Ltd.: 2 (https://510kreport.com/company/nantong-egens-biotech)
- Hangzhou Clongene Biotech Co., Ltd.: 2 (https://510kreport.com/company/hangzhou-clongene-biotech)
- Assure Tech., LLC: 1 (https://510kreport.com/company/assure-tech)
- Medtox Diagnostics, Inc.: 1 (https://510kreport.com/company/medtox-diagnostics)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)

## Its most-cited devices
- K142396: Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests (2014), cited by 8
- K142580: Chemtrue Multi-Panel DOA DIP Card Tests (2014), cited by 3
- K111322: Chemtrue Single/Multi-Panel Drug Screen Cassette/Dipcard (2011), cited by 2
- K102203: Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests (2011), cited by 2
- K123080: Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests (2012), cited by 1
- 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 (2023), cited by 1

## Recent decisions
- 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 (Dec 20, 2023)
- K153192: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests (Apr 18, 2016)
- K143599: Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 (Apr 17, 2015)
- K142580: Chemtrue Multi-Panel DOA DIP Card Tests (Dec 1, 2014)
- K142396: Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests (Oct 9, 2014)
- K131931: Chemtrue (R) HCG Pregnancy Urine Midstream Test (Jul 26, 2013)
- K123844: Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test,  and HCG Combo Serum/Urine Cassette Test (May 30, 2013)
- K123080: Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests (Nov 29, 2012)

Source page: https://510kreport.com/company/chemtron-biotech