HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS

System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Acustar Anti-b2 Glycoprotein-i; Igg, Igm, Igg Controls, Igm Controls.

Pre-market Notification Details

• Device ID: K091556
• 510k Number: K091556
• Device Name: HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
• Classification: System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
• Applicant: INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730
• Contact: Carol Marble
• Correspondent: Carol Marble; INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730
• Product Code: MSV
• CFR Regulation Number: 866.5660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-27
• Decision Date: 2010-05-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08426951289271	K091556	000
08426951289264	K091556	000
08426950497028	K091556	000
08426950497011	K091556	000
08426950496984	K091556	000
08426950496977	K091556	000
08426950594475	K091556	000
08426950594420	K091556	000