Biochemical Diagnostics Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0328-2016 | Class III | CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT D | September 14, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid C | February 23, 2016 |
| K132688 | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | December 16, 2013 |