Cleared Traditional

K990627 - AUTOSTAT II ANTI-SS-A/RO ELISA
(FDA 510(k) Clearance)

K990627 · Cogent Diagnotics , Ltd. · Immunology

Apr 1999

Decision

62d

Days

Class 2

Risk

K990627 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-SS-A/RO ELISA, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on April 28, 1999, 62 days after receiving the submission on February 25, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K990627 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 1999
Decision Date	April 28, 1999
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement