Cleared Traditional

Aptiva APS IgG Reagent; Aptiva APS IgM Reagent

K223093 · Inova Diagnostics, Inc. · Immunology
Dec 2024
Decision
809d
Days
Class 2
Risk

About This 510(k) Submission

K223093 is an FDA 510(k) clearance for the Aptiva APS IgG Reagent; Aptiva APS IgM Reagent, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 17, 2024, 809 days after receiving the submission on September 30, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K223093 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date December 17, 2024
Days to Decision 809 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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