Id-Fish Technology, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242872 | iDart Lyme IgM ImmunoBlot Kit | June 12, 2025 |
| K233367 | iDart Lyme IgG ImmunoBlot Kit | August 12, 2024 |
| DEN160025 | ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit | August 18, 2017 |