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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 K982362
Device Name ABBOTT TESTPACK PLUS H. PYLORI
Applicant
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact Irene Powers
Correspondent
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact Irene Powers
Regulation Number866.3110
Classification Product Code
LYR  
Date Received07/06/1998
Decision Date 11/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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