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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Helicobacter Pylori
510(k) Number K024334
Device Name QUANTA LITE H.PYLORI 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 Number866.3110
Classification Product Code
LYR  
Date Received12/26/2002
Decision Date 03/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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