Cleared Traditional

K072967 - QUANTA LITE F-ACTIN IGA ELISA (FDA 510(k) Clearance)

K072967 · Inova Diagnostics, Inc. · Immunology device
Jan 2008
Decision
98d
Days
Class 2
Risk

K072967 is an FDA 510(k) clearance for the QUANTA LITE F-ACTIN IGA ELISA. This device is classified as a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II - Special Controls, product code MVM).

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 28, 2008, 98 days after receiving the submission on October 22, 2007.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K072967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2007
Decision Date January 28, 2008
Days to Decision 98 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MVM — Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.5660