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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
510(k) Number K010558
Device Name QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) 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 Number866.5110
Classification Product Code
MLE  
Date Received02/26/2001
Decision Date 04/03/2001
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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