Cleared Traditional

K982366 - QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA (FDA 510(k) Clearance)

K982366 · Inova Diagnostics, Inc. · Immunology device
Aug 1998
Decision
51d
Days
Class 2
Risk

K982366 is an FDA 510(k) clearance for the QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) 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 August 27, 1998, 51 days after receiving the submission on July 7, 1998.

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

Submission Details

510(k) Number K982366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1998
Decision Date August 27, 1998
Days to Decision 51 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