FDA 510(k)

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL

Número K: K192345 · 2019-10-31

Data da decisão2019-10-31

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2019-10-31 under 510(k) number K192345. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL?

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL is a medical device that received FDA 510(k) clearance on 2019-10-31. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K192345.

When did MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL receive FDA 510(k) clearance?

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL received FDA 510(k) clearance on 2019-10-31, under 510(k) number K192345.

Who is the listed applicant for MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL?

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

What is the FDA product code for MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL?

The FDA product code for MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL is JWY.

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Outros registros que listam Liofilchem s.r.l. como candidato(a)

K260696MTS Gepotidacin 0.016-256 µg/mL K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)K243202MTS Ceftobiprole 0.002-32 µg/mL K230479ComASP Cefiderocol 0.008-128 K211672MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

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Dispositivos Relacionados (Código: JWY)

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Fonte oficial

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