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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 K001177
Device Name PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
Applicant
Enteric Products, Inc.
25 E. Loop Dr.
Stony Brook,  NY  11790
Applicant Contact JEFFREY PEACOCK
Correspondent
Enteric Products, Inc.
25 E. Loop Dr.
Stony Brook,  NY  11790
Correspondent Contact JEFFREY PEACOCK
Regulation Number866.3110
Classification Product Code
LYR  
Date Received04/11/2000
Decision Date 11/13/2000
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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