Cleared Traditional

ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

K003069 · Quest Intl., Inc. · Immunology
Nov 2000
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K003069 is an FDA 510(k) clearance for the ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on November 27, 2000, 56 days after receiving the submission on October 2, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K003069 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2000
Decision Date November 27, 2000
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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