Cleared Traditional

DIASTAT ENA PROFILE

K905190 · Shield Diagnostics, Ltd. · Immunology
Dec 1990
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K905190 is an FDA 510(k) clearance for the DIASTAT ENA PROFILE, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Shield Diagnostics, Ltd. (Scotland, KN). The FDA issued a Cleared decision on December 7, 1990, 18 days after receiving the submission on November 19, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K905190 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1990
Decision Date December 07, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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