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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K051218
Device Name MODIFICATION TO: UNICAP SPECIFIC IGE
Applicant
Pharmacia Diagnostics AB
4169 Commercial Ave.
Portage,  MI  49002
Applicant Contact MARTIN R MANN
Correspondent
Pharmacia Diagnostics AB
4169 Commercial Ave.
Portage,  MI  49002
Correspondent Contact MARTIN R MANN
Regulation Number866.5750
Classification Product Code
DHB  
Date Received05/12/2005
Decision Date 06/09/2005
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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