Cleared Traditional

K982121 - ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
(FDA 510(k) Clearance)

K982121 · Trace Scientific , Ltd. · Immunology

Sep 1998

Decision

93d

Days

Class 2

Risk

K982121 is an FDA 510(k) clearance for the ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT. This device is classified as a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM).

Submitted by Trace Scientific , Ltd. (Miami, US). The FDA issued a Cleared decision on September 17, 1998, 93 days after receiving the submission on June 16, 1998.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K982121 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 1998
Decision Date	September 17, 1998
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5090