Biotest Diagnostics Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K991650 | CMV BRITE TURBO KIT | July 12, 1999 |
| K983842 | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | June 9, 1999 |
| K983841 | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | June 9, 1999 |
| K983839 | BIOTEST ANTI-EBV RECOMBINANT | June 9, 1999 |
| K951550 | CMV BRITE ANTIGENEMIA TEST KIT | January 30, 1996 |