LDJ — Enzyme Immunoassay, Cannabinoids Class II
FDA product code LDJ covers "Enzyme Immunoassay, Cannabinoids", a Class II medical device regulated under 21 CFR 862.3870. 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
- LDJ
- Device Class
- Class II
- Regulation Number
- 862.3870
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232732 | co-innovation biotech co | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapi | January 17, 2024 |
| K232604 | hangzhou laihe biotech co | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test | January 10, 2024 |
| K223162 | healgen scientific | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test C | March 17, 2023 |
| K192515 | shenzhen bioeasy biotechnology co | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY | October 11, 2019 |
| K153741 | hangzhou clongene biotech co | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test | March 18, 2016 |
| K152643 | nantong egens biotech co | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Te | November 2, 2015 |
| K151203 | immunalysis corporation | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibr | June 5, 2015 |
| K141320 | lin-zhi international | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Cali | May 28, 2015 |
| K142408 | polymed therapeutics | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep | September 25, 2014 |
| K140546 | healgen scientific | HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST | June 6, 2014 |
| K132096 | biophor diagnostics | RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECT | October 18, 2013 |
| K130213 | lumiquick diagnostics | QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE | October 18, 2013 |
| K122633 | branan medical | TOXCUP DRUG SCREEN CUP | February 7, 2013 |
| K122759 | omega laboratories | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) | December 5, 2012 |
| K121557 | guangzhou wondfo biotech co | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST | July 25, 2012 |
| K111929 | psychemedics | PSYCHEMEDICS CANNABINOIDS EIA | May 1, 2012 |
| K102428 | hien helen nguyen | WUNDER TEST | April 18, 2012 |
| K110239 | lin-zhi international | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | June 23, 2011 |
| K110182 | guangzhou wondfo biotech co | CANNABINOIDS URINE TEST | May 20, 2011 |
| K092269 | randox laboratories | CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET | April 8, 2011 |