Branan Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 11
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2311-2016 | Class III | AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup | July 5, 2016 |
| Z-1508-2014 | Class II | ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening devi | March 26, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K103227 | ORATECT ORAL FLUID DRUG SCREEN DEVICES | April 11, 2012 |
| K082508 | FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD | November 21, 2008 |
| K002342 | BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST | November 27, 2000 |
| K002265 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST | November 27, 2000 |
| K002264 | BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST | November 27, 2000 |
| K002268 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST | November 27, 2000 |
| K002418 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D | November 22, 2000 |
| K002587 | BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST | November 22, 2000 |
| K002417 | BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D | November 22, 2000 |
| K002337 | BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST | November 22, 2000 |
| K002266 | BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST | November 22, 2000 |