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FDA 510(k)

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.

N.º K: K242843 · 2025-06-20

SolicitanteThermo Fisher Scientific
Fecha de decisión2025-06-20
Código de productoJWY
Comité asesorMI
DecisiónSubstantially Equivalent

Resumen del dispositivo

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K242843. 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 The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.?

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K242843.

When did The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. receive FDA 510(k) clearance?

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. received FDA 510(k) clearance on 2025-06-20, under 510(k) number K242843.

Who is the listed applicant for The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.?

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.?

The FDA product code for The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. is JWY.

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Fuente oficial

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