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.
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 |
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 |