DKZ — Enzyme Immunoassay, Amphetamine Class II
FDA product code DKZ covers "Enzyme Immunoassay, Amphetamine", a Class II medical device regulated under 21 CFR 862.3100. 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
- DKZ
- Device Class
- Class II
- Regulation Number
- 862.3100
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240670 | microgenics corporation | DRI Ecstasy Plus Assay | October 30, 2024 |
| K233019 | hangzhou alltest biotech co | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest | December 13, 2023 |
| K231137 | xenta biomedical science co | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | May 19, 2023 |
| K200363 | quidel cardiovascular | Quidel Triage® TOX Drug Screen, 94600 | March 11, 2020 |
| K191099 | atlas medical | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | October 3, 2019 |
| K182719 | quidel cardiovascular | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | June 19, 2019 |
| K182738 | hangzhou alltest biotech co | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul | March 27, 2019 |
| K180879 | shanghai venture bio-tech co | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- | December 14, 2018 |
| K181945 | phamatech | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | October 18, 2018 |
| K173303 | alfa scientific designs | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT | February 23, 2018 |
| K161251 | hangzhou clongene biotech co | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests | August 30, 2016 |
| K152122 | alfa scientific designs | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine | June 24, 2016 |
| K152908 | ucp biosciences | UCP COMPACT DRUG TESTS | May 3, 2016 |
| K152590 | coretests | ACCU NEWS Drug Screening Test Card/Urine Cup | April 15, 2016 |
| K153465 | assure tech. (hangzhou) co | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), A | March 31, 2016 |
| K152269 | healgen scientific | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test | September 9, 2015 |
| K151213 | ucp biosciences | UCP Drug Test Mini Cups | August 21, 2015 |
| K142855 | omega laboratories | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-me | July 28, 2015 |
| K141748 | biophor diagnostics | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CAL | May 20, 2015 |
| K143500 | immunalysis corporation | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine | February 6, 2015 |