Cleared Traditional

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM

K013628 · Diamedix Corp. · Immunology
Dec 2001
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K013628 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on December 21, 2001, 46 days after receiving the submission on November 5, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K013628 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2001
Decision Date December 21, 2001
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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