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510(k) K031177

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M by Axis-Shield Diagnostics, Ltd. — Product Code MSV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2003
Date Received
April 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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