Cleared Traditional

ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM

K932225 · Immuno Concepts, Inc. · Immunology
Jul 1993
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K932225 is an FDA 510(k) clearance for the ANTI-CARDIOLIPIN ANTIBODY SCREENING 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 July 6, 1993, 60 days after receiving the submission on May 7, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K932225 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1993
Decision Date July 06, 1993
Days to Decision 60 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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