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FDA 510(k)

Laboratorios Biogalenic Sterile Water for Inhalation, USP

K-Number: K251419 · 2026-01-14

ApplicantLaboratorios Biogalenic S.A. DE C.V.
Decision Date2026-01-14
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Laboratorios Biogalenic Sterile Water for Inhalation, USP is a medical device manufactured by Laboratorios Biogalenic S.A. DE C.V.. It received FDA 510(k) clearance on 2026-01-14 under approval number K251419. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laboratorios Biogalenic Sterile Water for Inhalation, USP?

Laboratorios Biogalenic Sterile Water for Inhalation, USP is a medical device that received FDA 510(k) clearance on 2026-01-14. It is manufactured by Laboratorios Biogalenic S.A. DE C.V.. The 510(k) number is K251419.

When was Laboratorios Biogalenic Sterile Water for Inhalation, USP approved by the FDA?

Laboratorios Biogalenic Sterile Water for Inhalation, USP received FDA 510(k) clearance on 2026-01-14, under approval number K251419.

What company makes Laboratorios Biogalenic Sterile Water for Inhalation, USP?

Laboratorios Biogalenic Sterile Water for Inhalation, USP is manufactured by Laboratorios Biogalenic S.A. DE C.V..

What is the FDA product code for Laboratorios Biogalenic Sterile Water for Inhalation, USP?

The FDA product code for Laboratorios Biogalenic Sterile Water for Inhalation, USP is BTT.

Other Devices by Laboratorios Biogalenic S.A. DE C.V.

K243001Sterile Water USP and Sterile 0.9% Normal Saline USP K242717Laboratorios Biogalenic Sterile Water for Inhalation, USP

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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