FDA 510(k)

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

N.º K: K192050 · 2019-09-27

Fecha de decisión2019-09-27

Código de productoJWY

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

ETEST Eravacycline (ERV) (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 2019-09-27 under 510(k) number K192050. 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 Eravacycline (ERV) (0.002 – 32 µg/mL)?

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Biomerieux S.A.. The 510(k) number is K192050.

When did ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) receive FDA 510(k) clearance?

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) received FDA 510(k) clearance on 2019-09-27, under 510(k) number K192050.

Who is the listed applicant for ETEST Eravacycline (ERV) (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 Eravacycline (ERV) (0.002 – 32 µg/mL)?

The FDA product code for ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) is JWY.

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

K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)K183031ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

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Dispositivos relacionados (Código: JWY)

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Fuente oficial

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