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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
510(k) Number K000733
Device Name QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
Applicant
Inova Diagnostics, Inc.
10180 Scripps Ranch Blvd.
San Diego,  CA  92131
Applicant Contact BRYS C MYERS
Correspondent
Inova Diagnostics, Inc.
10180 Scripps Ranch Blvd.
San Diego,  CA  92131
Correspondent Contact BRYS C MYERS
Regulation Number866.5785
Classification Product Code
NBT  
Date Received03/06/2000
Decision Date 05/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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