Atlas FDA

Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)

FDA 510(k) clearance K150556 · decided 2015-08-28

Clearance details

K-number
K150556
Device name
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
Applicant
Thermo Fisher Scientific
Decision
Substantially Equivalent
Date received
2015-03-04
Decision date
2015-08-28
Days to decision
177 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.