Laboratorios Biogalenic S.A. DE C.V.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | January 14, 2026 |
| K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | March 6, 2025 |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | January 30, 2025 |