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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 -0285
Applicant Contact JOHN WALTER
Correspondent
DIASORIN, INC.
1951 NORTHWESTERN AVE.
STILLWATER,  MN  55082 -0285
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
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