Aptiva Celiac Disease IgG Reagent— 510(k) K200230

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K200230 for Aptiva Celiac Disease IgG Reagent, Substantially Equivalent on 2021-08-26. Applicant: Inova Diagnostics, Inc..

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code MVM
Advisory panel: Immunology
Date received: 2020-01-30
Decision date: 2021-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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