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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
510(k) Number K092757
Device Name THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
Applicant
Thera-Test Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Applicant Contact MARIUS TEODORESCU
Correspondent
Thera-Test Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Correspondent Contact MARIUS TEODORESCU
Regulation Number866.5660
Classification Product Code
MSV  
Date Received09/09/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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