Cleared Traditional

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

K031177 · Axis-Shield Diagnostics, Ltd. · Immunology
Jun 2003
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K031177 is an FDA 510(k) clearance for the DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on June 19, 2003, 66 days after receiving the submission on April 14, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K031177 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2003
Decision Date June 19, 2003
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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