Cleared Traditional

DIASTAT ENA SINGLE WELL SCREEN KIT

K944505 · Shield Diagnostics, Ltd. · Immunology
Nov 1994
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K944505 is an FDA 510(k) clearance for the DIASTAT ENA SINGLE WELL SCREEN KIT, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on November 21, 1994, 68 days after receiving the submission on September 14, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K944505 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1994
Decision Date November 21, 1994
Days to Decision 68 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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