Cleared Traditional

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

K020156 · Axis-Shield Diagnostics, Ltd. · Immunology
Mar 2002
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K020156 is an FDA 510(k) clearance for the DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on March 6, 2002, 48 days after receiving the submission on January 17, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K020156 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2002
Decision Date March 06, 2002
Days to Decision 48 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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