K152013

Substantially Equivalent

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

Applicant: Inova Diagnostics, Inc.
Product code: LSW
Advisory panel: Immunology
Date received: 2015-07-21
Decision date: 2016-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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