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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 K161139
Device Name LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Applicant Contact JOHN WALTER
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Correspondent Contact KELLY R. SAUER
Regulation Number866.3110
Classification Product Code
LYR  
Subsequent Product Codes
JJQ   JJX  
Date Received04/22/2016
Decision Date 07/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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