510(k) K161258— NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

Substantially Equivalent

Inova Diagnostics, Inc.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code MOB
Advisory panel: Immunology
Date received: 2016-05-04
Decision date: 2017-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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