Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)— 510(k) K150556

Clearance details

Applicant

Thermo Fisher Scientific

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2015-03-04

Decision date

2015-08-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oakwood Village, OH, US

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