Cleared Traditional

DIASTAT ANTI-CENTROMERE KIT

K932877 · Shield Diagnostics, Ltd. · Immunology
Oct 1993
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K932877 is an FDA 510(k) clearance for the DIASTAT ANTI-CENTROMERE 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 October 15, 1993, 123 days after receiving the submission on June 14, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K932877 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1993
Decision Date October 15, 1993
Days to Decision 123 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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