Aptiva APS IgG Reagent; Aptiva APS IgM Reagent— 510(k) K223093

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K223093 for Aptiva APS IgG Reagent; Aptiva APS IgM Reagent, Substantially Equivalent on 2024-12-17. Applicant: Inova Diagnostics, Inc..

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code MID
Advisory panel: Immunology
Date received: 2022-09-30
Decision date: 2024-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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