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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K061979
Device Name MODIFICATION TO MYALLERGY TEST
Applicant
Immunetech Corporation
888 Oak Grove, Suite 4
Menlo Park,  CA  94025
Applicant Contact NANCY BENSON
Correspondent
Immunetech Corporation
888 Oak Grove, Suite 4
Menlo Park,  CA  94025
Correspondent Contact NANCY BENSON
Regulation Number862.1675
Classification Product Code
JKA  
Date Received07/13/2006
Decision Date 09/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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