Cleared Traditional

AUTOSTAT II ANTI-SS-B/LA ELISA

K990626 · Cogent Diagnotics , Ltd. · Immunology
Apr 1999
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K990626 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-SS-B/LA 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 K990626 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

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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