Cleared Traditional

K091556 - HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I (FDA 510(k) Clearance)

Also includes:
IGG, IGM, IGG CONTROLS, IGM CONTROLS
K091556 · Instrumentation Laboratory CO · Immunology device
May 2010
Decision
359d
Days
Class 2
Risk

K091556 is an FDA 510(k) clearance for the HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I. This device is classified as a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II - Special Controls, product code MSV).

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on May 21, 2010, 359 days after receiving the submission on May 27, 2009.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K091556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2009
Decision Date May 21, 2010
Days to Decision 359 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