K100148

Substantially Equivalent

SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500

Applicant: Focus Diagnostics, Inc.
Product code: OQW
Advisory panel: Microbiology
Date received: 2010-01-19
Decision date: 2010-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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