Cleared Traditional

AUTOSTAT II ANTI-THYROGLOBULIN

K943625 · Cogent Diagnotics , Ltd. · Immunology
Dec 1994
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K943625 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-THYROGLOBULIN, a Thyroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDC), submitted by Cogent Diagnotics , Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on December 22, 1994, 149 days after receiving the submission on July 26, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K943625 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1994
Decision Date December 22, 1994
Days to Decision 149 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DDC — Thyroglobulin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

Similar Devices — DDC Thyroglobulin, Antigen, Antiserum, Control

All 12
SERAQUEST ANTI-THYROGLOBULIN
K023592 · Quest Intl., Inc. · Jan 2003
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
K012208 · Beckman Coulter, Inc. · Sep 2001
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K000363 · Zeus Scientific, Inc. · Feb 2000
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
K991610 · Zeus Scientific, Inc. · Jun 1999
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K991179 · Zeus Scientific, Inc. · Jun 1999
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
K971835 · Monobind · Jul 1997