K141328

Substantially Equivalent

QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS

Applicant: Inova Diagnostics, Inc.
Product code: LLL
Advisory panel: Immunology
Date received: 2014-05-21
Decision date: 2015-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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