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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 K970551
Device Name QUANTA LITE B2GPI IGG
Applicant
Inova Diagnostics, Inc.
10451 Roselle St.
San Diego,  CA  92121
Applicant Contact BRYS C MYERS
Correspondent
Inova Diagnostics, Inc.
10451 Roselle St.
San Diego,  CA  92121
Correspondent Contact BRYS C MYERS
Regulation Number866.5660
Classification Product Code
MSV  
Date Received02/12/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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