Cleared Traditional

DIASTAT ANTI-HISTONE KIT

K920616 · Shield Diagnostics, Ltd. · Immunology
Jul 1992
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K920616 is an FDA 510(k) clearance for the DIASTAT ANTI-HISTONE KIT, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on July 14, 1992, 154 days after receiving the submission on February 11, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K920616 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1992
Decision Date July 14, 1992
Days to Decision 154 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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