Cleared Traditional

AUTOSTAT II ENA SCREEN ELISA

K983921 · Cogent Diagnotics , Ltd. · Immunology
Dec 1998
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K983921 is an FDA 510(k) clearance for the AUTOSTAT II ENA SCREEN 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 December 28, 1998, 54 days after receiving the submission on November 4, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K983921 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1998
Decision Date December 28, 1998
Days to Decision 54 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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