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FDA 510(k)

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml

K-Number: K183033 · 2019-01-04

ApplicantThermo Fisher Scientific
Decision Date2019-01-04
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml is a medical device manufactured by Thermo Fisher Scientific. It received FDA 510(k) clearance on 2019-01-04 under approval number K183033. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml?

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml is a medical device that received FDA 510(k) clearance on 2019-01-04. It is manufactured by Thermo Fisher Scientific. The 510(k) number is K183033.

When was Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml approved by the FDA?

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml received FDA 510(k) clearance on 2019-01-04, under approval number K183033.

What company makes Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml?

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml is manufactured by Thermo Fisher Scientific.

What is the FDA product code for Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml?

The FDA product code for Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml is JWY.

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Other Devices by Thermo Fisher Scientific

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Related Devices (Code: JWY)

K162854Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/mlLiofilchem s.r.l. K161175Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mLLiofilchem s.r.l. K153569Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/mlLiofilchem s.r.l. K153687Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mLLiofilchem s.r.l. K173307Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mLLiofilchem s.r.l. K173209Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mLThermo Fisher Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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