Cleared Traditional

K925826 - ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA
(FDA 510(k) Clearance)

K925826 · Clark Laboratories, Inc. · Immunology

Jan 1993

Decision

71d

Days

Class 2

Risk

K925826 is an FDA 510(k) clearance for the ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA. This device is classified as a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO).

Submitted by Clark Laboratories, Inc. (Blairstown, US). The FDA issued a Cleared decision on January 26, 1993, 71 days after receiving the submission on November 16, 1992.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number	K925826 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 1992
Decision Date	January 26, 1993
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF