Cleared Traditional

K101644 - QUANTA FLASH H-TTG IGG (FDA 510(k) Clearance)

K101644 · Inova Diagnostics, Inc. · Immunology device
Mar 2011
Decision
286d
Days
Class 2
Risk

K101644 is an FDA 510(k) clearance for the QUANTA FLASH H-TTG IGG. 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 March 23, 2011, 286 days after receiving the submission on June 10, 2010.

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

Submission Details

510(k) Number K101644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2010
Decision Date March 23, 2011
Days to Decision 286 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