DIS — Enzyme Immunoassay, Barbiturate Class II
FDA Device Classification
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 |
| K070098 | phamatech | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN | December 7, 2007 |
| K070009 | phamatech | AT HOME DRUG TEST MODELS, 9308T AND 9308X | 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 |
| K042975 | ameditech | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | December 29, 2004 |
| K043211 | roche diagnostics | ONLINE DAT BARBITURATES PLUS | 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 |