Cleared Traditional

DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM

K012053 · Diamedix Corp. · Immunology
Aug 2001
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K012053 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on August 20, 2001, 49 days after receiving the submission on July 2, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K012053 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2001
Decision Date August 20, 2001
Days to Decision 49 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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