Cleared Traditional

ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM

K911661 · Immuno Concepts, Inc. · Immunology
Dec 1991
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K911661 is an FDA 510(k) clearance for the ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on December 9, 1991, 241 days after receiving the submission on April 12, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K911661 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1991
Decision Date December 09, 1991
Days to Decision 241 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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