Cleared Traditional

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN

K013956 · Diamedix Corp. · Immunology
Jan 2002
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K013956 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN, 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 January 8, 2002, 39 days after receiving the submission on November 30, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K013956 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2001
Decision Date January 08, 2002
Days to Decision 39 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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