Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests
FDA 510(k) K123080 · Chemtron Biotech, Inc.
510(k) numberK123080
Submission
- Device name
- Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests
- Applicant
- Chemtron Biotech, Inc.
San Diego, CA, US - Received
- October 1, 2012
- Decision date
- November 29, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JXM – Enzyme Immunoassay, Benzodiazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3170
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent KitJXM · Special | Microgenics Corporation | 12/11/2024SE |
| K221765 | ONLINE DAT Benzodiazepines IIJXM · Traditional | Roche Diagnostics | 12/23/2022SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | Microgenics Corporation | 12/09/2019SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | Microgenics Corporation | 02/21/2018SE |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in HairJXM · Traditional | Psychemedics Corporation | 09/15/2017SE |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 08/02/2017SE |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 05/23/2016SE |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM · Traditional | Immunalysis Corporation | 01/05/2016SE |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 08/13/2015SE |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 05/13/2015SE |
More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…DJG · Traditional | 12/20/2023SE |
| 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 |
| 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 Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests cleared by the FDA?
Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette Tests (K123080) received a 510(k) decision of Substantially Equivalent on November 29, 2012, 59 days after the submission was received.
What is the product code of K123080?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.