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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K132631
Device Name EIA SMDP IMMUNOASSAY
Applicant
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Applicant Contact MARTIN ROBERT MANN
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Correspondent Contact MARTIN ROBERT MANN
Regulation Number866.5100
Classification Product Code
LKP  
Date Received08/22/2013
Decision Date 08/29/2014
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
Recalls CDRH Recalls
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