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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Antigen, Antiserum, Control
510(k) Number K862183
Device Name DAKO ITA, IMMUNOGLOBULIN A (IGA)
Applicant
Dako Corp.
22 N. Milpas St.
Santa Barbara,  CA  93103
Applicant Contact BROOKS, PH.D.
Correspondent
Dako Corp.
22 N. Milpas St.
Santa Barbara,  CA  93103
Correspondent Contact BROOKS, PH.D.
Regulation Number866.5510
Classification Product Code
CZP  
Date Received06/09/1986
Decision Date 08/19/1986
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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