FDA 510(k)

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL

N.º K: K180886 · 2018-05-18

Fecha de decisión2018-05-18

Código de productoJWY

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/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 2018-05-18 under 510(k) number K180886. 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 Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL?

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K180886.

When did Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL receive FDA 510(k) clearance?

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180886.

Who is the listed applicant for Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/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 Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL?

The FDA product code for Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 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 Liofilchem s.r.l. como solicitante

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

Ver todos los 35 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.