FDA 510(k)

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml

K-Number: K221899 · 2023-01-20

Decision Date2023-01-20

Product CodeNGZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/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 2023-01-20 under 510(k) number K221899. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml?

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K221899.

When did The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml receive FDA 510(k) clearance?

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml received FDA 510(k) clearance on 2023-01-20, under 510(k) number K221899.

Who is the listed applicant for The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/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 YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml?

The FDA product code for The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml is NGZ.

Other records listing Thermo Fisher Scientific as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL K250990The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL K242843The 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.K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL

View all 41 devices →

Related Devices (Code: NGZ)

K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher Scientific K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc.K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.K231433The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mLThermo Fisher Scientific K221198Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mLThermo Fisher Scientific K211539Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 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.