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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 K862368
Device Name AMPLIFIED ELISA IGE KIT
Applicant
Allertec, Inc.
490 Post Stree, Suite 1230
San Francisco,  CA  94102
Applicant Contact ANTHONY MATHEWS
Correspondent
Allertec, Inc.
490 Post Stree, Suite 1230
San Francisco,  CA  94102
Correspondent Contact ANTHONY MATHEWS
Regulation Number866.5510
Classification Product Code
DGC  
Date Received06/24/1986
Decision Date 07/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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