Cleared Traditional

AUTOSTAT II ENA-6 PROFILE ELISA

K003054 · Cogent Diagnotics , Ltd. · Immunology
Oct 2000
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K003054 is an FDA 510(k) clearance for the AUTOSTAT II ENA-6 PROFILE 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 October 13, 2000, 11 days after receiving the submission on October 2, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K003054 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2000
Decision Date October 13, 2000
Days to Decision 11 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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