DIS — Enzyme Immunoassay, Barbiturate Class II
FDA product code DIS covers "Enzyme Immunoassay, Barbiturate", a Class II medical device regulated under 21 CFR 862.3150. 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
- DIS
- Device Class
- Class II
- Regulation Number
- 862.3150
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161714 | immunalysis corporation | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibr | October 14, 2016 |
| K151211 | assure tech. co | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbit | June 4, 2015 |
| K150791 | healgen scientific | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphin | April 24, 2015 |
| K143535 | guangzhou wondfo biotech co | CR3 Keyless Split Sample Cup Secobarbital- Methadone | January 13, 2015 |
| K140665 | genprime | GenPrime Snap-Top Split Key Cup | December 8, 2014 |
| K140215 | co-innovation biotech co | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | June 16, 2014 |
| K092268 | randox laboratories | RANDOX BARITURATES ASSAY | May 25, 2011 |
| K110515 | ucp biosciences | UCP DRUG SCREENING TEST CUPS | April 20, 2011 |
| K070009 | phamatech | AT HOME DRUG TEST MODELS, 9308T AND 9308X | December 7, 2007 |
| K070098 | phamatech | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN | December 7, 2007 |
| K062165 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT | January 5, 2007 |
| K050024 | guangzhou wondfo biotech co | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS | November 17, 2005 |
| K050593 | acon laboratories | ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE | May 6, 2005 |
| K043211 | roche diagnostics | ONLINE DAT BARBITURATES PLUS | December 29, 2004 |
| K042975 | ameditech | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | December 29, 2004 |
| K041143 | randox laboratories | RANDOX BARBITURATE ASSAY | November 5, 2004 |
| K041712 | american bio medica | 'RAPIDTEC 4' TEST | November 3, 2004 |
| K033885 | lin-zhi international | BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) | May 19, 2004 |
| K033334 | medtox diagnostics | PROFILE -ER | November 10, 2003 |
| K032764 | lin-zhi international | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TEST | November 3, 2003 |