The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL

FDA 510(k) K250990 · Thermo Fisher Scientific

Substantially Equivalent

510(k) numberK250990

Submission

Device name
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
Applicant
Thermo Fisher Scientific
Oakwood Village, OH, US
Received
March 31, 2025
Decision date
June 30, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JWY – Manual Antimicrobial Susceptibility Test Systems
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Specialty
Microbiology

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More from Thermo Fisher Scientific

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K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with…JWY · Traditional 09/05/2025SE
K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the…JWY · Traditional 08/28/2025SE
K242843The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional 06/20/2025SE
K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the…JWY · Traditional 05/22/2025SE
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Questions and answers

When was The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL cleared by the FDA?

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (K250990) received a 510(k) decision of Substantially Equivalent on June 30, 2025, 91 days after the submission was received.

What is the product code of K250990?

The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.