DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites Class II
FDA product code DIO covers "Enzyme Immunoassay, Cocaine And Cocaine Metabolites", a Class II medical device regulated under 21 CFR 862.3250. 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
- DIO
- Device Class
- Class II
- Regulation Number
- 862.3250
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213211 | carolina liquid chemistries | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (C | January 27, 2022 |
| K211973 | microgenics corporation | DRI Cocaine Metabolite Assay | September 24, 2021 |
| K191638 | medtest dx | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | March 12, 2020 |
| K181499 | microgenics corporation | DRI Cocaine Metabolite Assay | July 6, 2018 |
| K170293 | siemens healthcare diagnostics | Emit II Plus Cocaine Metabolite Assay | October 25, 2017 |
| K163570 | carolina liquid chemistries corporation | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | August 15, 2017 |
| K162395 | mp biomedicals | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup | June 2, 2017 |
| K152232 | quest diagnostics incorporated | Quest Diagnostics HairCheck-DT (Cocaine) | November 18, 2016 |
| K161214 | guangzhou wondfo biotech co | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test | June 27, 2016 |
| K153646 | safecare biotech (hangzhou) co | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes | March 18, 2016 |
| K142129 | biophor diagnostics | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR | July 24, 2015 |
| K150925 | immunalysis corporation | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonin | June 29, 2015 |
| K142353 | w.h.p.m | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | October 7, 2014 |
| K141647 | healgen scientific | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP | July 17, 2014 |
| K131128 | omega laboratories | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | November 13, 2013 |
| K131754 | guangzhou wondfo biotech co | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) | July 31, 2013 |
| K121166 | guangzhou wondfo biotech co | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL | May 8, 2012 |
| K113751 | randox laboratories | RANDOX COCAINE METABOLITE | May 8, 2012 |
| K103227 | branan medical corporation | ORATECT ORAL FLUID DRUG SCREEN DEVICES | April 11, 2012 |
| K103295 | phamatech | QUICKSCREEN COCAINE 150 SCREENING TEST | February 1, 2012 |