Cleared Traditional

QUANTA Flash HMGCR Reagents

K180975 · Inova Diagnostics, Inc. · Immunology
Jun 2018
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K180975 is an FDA 510(k) clearance for the QUANTA Flash HMGCR Reagents, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 25, 2018, 73 days after receiving the submission on April 13, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K180975 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2018
Decision Date June 25, 2018
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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