510(k) K190088— QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

Substantially Equivalent

Inova Diagnostics, Inc.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code DHR
Advisory panel: Immunology
Date received: 2019-01-17
Decision date: 2019-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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