K160729

Substantially Equivalent

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

Applicant: Roche Diagnostics
Product code: PMT
Advisory panel: Microbiology
Date received: 2016-03-16
Decision date: 2016-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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