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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tryptase Assay System
510(k) Number K173704
Device Name ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
Applicant
Phadia AB
Rapsgatan 7p
Uppsala,  SE 751 37
Applicant Contact Carina Magnusson
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portae,  MI  49002
Correspondent Contact Martin Mann
Regulation Number866.5760
Classification Product Code
OYL  
Date Received12/04/2017
Decision Date 03/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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