FDA 510(k)

Sulopenem SPM 2 µg

N.º K: K251879 · 2025-08-12

Fecha de decisión2025-08-12

Código de productoJTN

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sulopenem SPM 2 µg is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K251879. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sulopenem SPM 2 µg?

Sulopenem SPM 2 µg is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Liofilchem. The 510(k) number is K251879.

When did Sulopenem SPM 2 µg receive FDA 510(k) clearance?

Sulopenem SPM 2 µg received FDA 510(k) clearance on 2025-08-12, under 510(k) number K251879.

Who is the listed applicant for Sulopenem SPM 2 µg?

The FDA 510(k) record lists Liofilchem as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sulopenem SPM 2 µg?

The FDA product code for Sulopenem SPM 2 µg is JTN.

Ensayos clínicos relacionados

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Fuente oficial

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