Product code DJG: 510(k) clearances and predicates
Product code DJG covers Labcorp Fentanyl Urine Visual Test. FDA lists 215 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
215 clearances on file under product code DJG. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 10 |
| 2024 | 5 |
| 2025 | 3 |
| 2026 so far | 3 |
Recent clearances
Newest DJG clearances in the FDA index, with applicant and decision date:
- K252684, Labcorp Fentanyl Urine Visual Test, applicant Medtox Diagnostics, Inc., decided 2026-01-29. FDA record
- K250741, Evidence MultiSTAT DOA Urine MultiPlex, applicant Randox Laboratories Limited, decided 2026-01-23. FDA record
- K253082, LZI Buprenorphine II Enzyme Immunoassay, applicant Lin-Zhi International, Inc., decided 2026-01-16. FDA record
- K252520, SEFRIA Hydrocodone Oral Fluid, applicant Immunalysis Corporation, decided 2025-09-11. FDA record
- K251972, Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180), applicant Healgen Scientific,, LLC, decided 2025-08-15. FDA record
- K251634, LZI Fentanyl III Enzyme Immunoassay, applicant Lin-Zhi International, Inc., decided 2025-06-18. FDA record
- K240124, BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader, applicant Vivachek Biotech (Hangzhou) Co., Ltd., decided 2024-06-14. FDA record
- K240698, Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard, applicant Guangzhou Decheng Biotechnology Co., Ltd., decided 2024-05-10. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Evidence MultiSTAT DOA Urine MultiPlex, LZI Buprenorphine II Enzyme Immunoassay. Watch new DJG clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DJG?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DJG clearances include Labcorp Fentanyl Urine Visual Test.
How many 510(k) clearances use product code DJG?
215 at the time this page was generated, from openFDA records.
How do I find a predicate device under DJG?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DJG clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.