Cleared Traditional

K011566 - QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA (FDA 510(k) Clearance)

K011566 · Inova Diagnostics, Inc. · Immunology device
Jul 2001
Decision
49d
Days
Class 2
Risk

K011566 is an FDA 510(k) clearance for the QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) 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 July 9, 2001, 49 days after receiving the submission on May 21, 2001.

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

Submission Details

510(k) Number K011566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date July 09, 2001
Days to Decision 49 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