Atlas FDA

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL

FDA 510(k) clearance K182797 · decided 2018-11-30

Clearance details

K-number
K182797
Device name
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
Applicant
Thermo Fisher Scientific
Decision
Substantially Equivalent
Date received
2018-10-01
Decision date
2018-11-30
Days to decision
60 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.