Laboratorios Biogalenic, S.A. de C.V.
Soyapango San Salvador, SV
Laboratorios Biogalenic, S.A. de C.V. appears in FDA device records in Soyapango San Salvador, SV. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Laboratorios Biogalenic, S.A. de C.V. between 2025 and 2026. The busiest year on record is 2025, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | BTT | Substantially Equivalent | |
| K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | FRO | Substantially Equivalent | |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | BTT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006785496 | 3006785496 | Laboratorios Biogalenic, S.A. de C.V. | Calle Claper Blvd. Del Ejercito Nacional km 5.5, Soyapango San Salvador 1639 SV SV | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain