Cleared Traditional

DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

K923886 · Shield Diagnostics, Ltd. · Immunology
Sep 1992
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K923886 is an FDA 510(k) clearance for the DIASTAT TOTAL ANTI-CARDIOLIPIN KIT, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on September 25, 1992, 52 days after receiving the submission on August 4, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K923886 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1992
Decision Date September 25, 1992
Days to Decision 52 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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