Cleared Traditional

DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

K012449 · Diamedix Corp. · Immunology
Oct 2001
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K012449 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM 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 October 26, 2001, 86 days after receiving the submission on August 1, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K012449 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2001
Decision Date October 26, 2001
Days to Decision 86 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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