FDA 510(k)

ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

N.º K: K192738 · 2019-11-26

Fecha de decisión2019-11-26

Código de productoJWY

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192738. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ETEST Delafloxacin (DFX) (0.002-32 µg/mL)?

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Biomerieux S.A.. The 510(k) number is K192738.

When did ETEST Delafloxacin (DFX) (0.002-32 µg/mL) receive FDA 510(k) clearance?

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192738.

Who is the listed applicant for ETEST Delafloxacin (DFX) (0.002-32 µg/mL)?

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

What is the FDA product code for ETEST Delafloxacin (DFX) (0.002-32 µg/mL)?

The FDA product code for ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is JWY.

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Otros registros que enlistan a Biomerieux S.A. como solicitante

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Fuente oficial

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