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510(k) K092757

THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR by Thera-Test Laboratories, Inc. — Product Code MSV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2009
Date Received
September 9, 2009
Clearance Type
Special
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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