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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 K843369
Device Name AGGLUTINATION TEST FOR TOTAL IGE
Applicant
Scientific Research
1249 Ambler
Abilene,  TX  79601
Applicant Contact SWAN
Correspondent
Scientific Research
1249 Ambler
Abilene,  TX  79601
Correspondent Contact SWAN
Regulation Number866.5510
Classification Product Code
DGC  
Date Received08/28/1984
Decision Date 11/14/1984
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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