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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K862014
Device Name IMMPULSE FERRITIN ASSAY REAGENT
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 Number866.5340
Classification Product Code
DBF  
Date Received05/28/1986
Decision Date 06/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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