FDA 510(k)

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

N.º K: K190154 · 2019-05-01

Fecha de decisión2019-05-01

Código de productoJWY

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/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 2019-05-01 under 510(k) number K190154. 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 Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)?

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is Biomerieux S.A.. The 510(k) number is K190154.

When did ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) receive FDA 510(k) clearance?

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) received FDA 510(k) clearance on 2019-05-01, under 510(k) number K190154.

Who is the listed applicant for ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/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 Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)?

The FDA product code for ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) is JWY.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)K183031ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: JWY)

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062El Sistema Sensititre 18-24 hora MIC o Sensibilidad de Punto de Ruptura con Colistina en el rango de dilución de 0.12-16 µg/mLThermo Fisher Scientific K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher Scientific K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.