Cleared Traditional

DIASTAT ANTI-CARDIOLIPIN KIT

K955303 · Shield Diagnostics, Ltd. · Immunology
May 1996
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K955303 is an FDA 510(k) clearance for the DIASTAT 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 May 30, 1996, 192 days after receiving the submission on November 20, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K955303 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1995
Decision Date May 30, 1996
Days to Decision 192 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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