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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 K900343
Device Name GAP-IGG
Applicant
Biomerica, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Applicant Contact PERRY G RUCKER
Correspondent
Biomerica, Inc.
1533 Monrovia Ave.
Newport Beach,  CA  92663
Correspondent Contact PERRY G RUCKER
Regulation Number866.3110
Classification Product Code
LYR  
Date Received01/23/1990
Decision Date 08/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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