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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K161899
Device Name ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
Applicant
Phadia AB
Rapsgatan 7p
Uppsala,  SE 751 37
Applicant Contact Ulf Karlberg
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact Martin Mann
Regulation Number866.5510
Classification Product Code
DGC  
Subsequent Product Code
DHB  
Date Received07/11/2016
Decision Date 07/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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