Atlas FDA

Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml

FDA 510(k) clearance K192729 · decided 2019-11-06

Clearance details

K-number
K192729
Device name
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
Applicant
Thermo Fisher Scientific
Decision
Substantially Equivalent
Date received
2019-09-27
Decision date
2019-11-06
Days to decision
40 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Oakwood Village, OH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.