Cleared Traditional

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

K190088 · Inova Diagnostics, Inc. · Immunology
Apr 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K190088 is an FDA 510(k) clearance for the QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 17, 2019, 90 days after receiving the submission on January 17, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K190088 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2019
Decision Date April 17, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

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