JXM — Enzyme Immunoassay, Benzodiazepine Class II
FDA product code JXM covers "Enzyme Immunoassay, Benzodiazepine", a Class II medical device regulated under 21 CFR 862.3170. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JXM
- Device Class
- Class II
- Regulation Number
- 862.3170
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243498 | microgenics corporation | Alinity c Benzodiazepines Reagent Kit | December 11, 2024 |
| K221765 | roche diagnostics | ONLINE DAT Benzodiazepines II | December 23, 2022 |
| K190968 | microgenics corporation | CEDIA Benzodiazepine Assay | December 9, 2019 |
| K173963 | microgenics corporation | DRI Benzodiazepine Assay | February 21, 2018 |
| K163590 | psychemedics corporation | Psychemedics Microplate EIA for Benzodiazepines in Hair | September 15, 2017 |
| K163704 | healgen scientific | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | August 2, 2017 |
| K153597 | healgen scientific | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | May 23, 2016 |
| K151771 | immunalysis corporation | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal | January 5, 2016 |
| K151642 | healgen scientific | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | August 13, 2015 |
| K150356 | healgen scientific | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | May 13, 2015 |
| K123080 | chemtron biotech | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS | November 29, 2012 |
| K111322 | chemtron biotech | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD | September 14, 2011 |
| K092274 | randox laboratories | RANDOX BENZODIAZEPINE ASSAY | October 15, 2010 |
| K062285 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND D | December 22, 2006 |
| K060354 | acro biotech | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 | July 28, 2006 |
| K051307 | beckman coulter | SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT | June 13, 2005 |
| K050179 | randox laboratories | RANDOX BENZODIAZEPINE CLASS ASSAY | May 17, 2005 |
| K043556 | beckman coulter | SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT | March 28, 2005 |
| K043327 | roche diagnostics | ONLINE DAT BENZODIAZEPINES PLUS | February 7, 2005 |
| K043167 | phamatech | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND | December 29, 2004 |