K151817

Substantially Equivalent

VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL

Applicant: bioMerieux, Inc.
Product code: NGZ
Advisory panel: Microbiology
Date received: 2015-07-06
Decision date: 2016-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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