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510(k) K022944

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA by Hycor Biomedical, Inc. — Product Code MSV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2002
Date Received
September 5, 2002
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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