Cleared Traditional

K983655 - AUTOSTAT II ANA SCREEN ELISA
(FDA 510(k) Clearance)

K983655 · Cogent Diagnotics , Ltd. · Immunology

Jan 1999

Decision

101d

Days

Class 2

Risk

K983655 is an FDA 510(k) clearance for the AUTOSTAT II ANA SCREEN ELISA. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM).

Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on January 28, 1999, 101 days after receiving the submission on October 19, 1998.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K983655 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1998
Decision Date	January 28, 1999
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement