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
FDA 510(k) K232736 · Chemtron Biotech, Inc.
510(k) numberK232736
Submission
- Device name
- 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
- Applicant
- Chemtron Biotech, Inc.
San Diego, CA, US - Received
- September 7, 2023
- Decision date
- December 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…DJG · Traditional | 04/18/2016SE |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000DJG · Traditional | 04/17/2015SE |
| K142580 | Chemtrue Multi-Panel DOA DIP Card TestsDKZ · Special | 12/01/2014SE |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsDJG · Traditional | 10/09/2014SE |
| K131931 | Chemtrue(R) HCG Pregnancy Urine Midstream TestLCX · Traditional | 07/26/2013SE |
| K123844 | Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional | 05/30/2013SE |
| K123080 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsJXM · Traditional | 11/29/2012SE |
| K121339 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsDKZ · Traditional | 05/17/2012SE |
| K111322 | Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardJXM · Traditional | 09/14/2011SE |
| K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsDKZ · Traditional | 01/20/2011SE |
Questions and answers
When was 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 cleared by the FDA?
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 (K232736) received a 510(k) decision of Substantially Equivalent on December 20, 2023, 104 days after the submission was received.
What is the product code of K232736?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.