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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Fitc, Antigen, Antiserum, Control
510(k) Number K863327
Device Name IMMPULSE IGE ASSAY REAGENTS
Applicant
Sclavo, Inc.
1240 Elko Dr.
Sunnyvale,  CA  94089
Applicant Contact MICHAEL BRINKLEY
Correspondent
Sclavo, Inc.
1240 Elko Dr.
Sunnyvale,  CA  94089
Correspondent Contact MICHAEL BRINKLEY
Regulation Number866.5510
Classification Product Code
DGP  
Date Received08/27/1986
Decision Date 12/03/1986
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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