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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lambda, Antigen, Antiserum, Control
510(k) Number K932136
Device Name DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)
Applicant
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact KIM KOSAI
Correspondent
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Correspondent Contact KIM KOSAI
Regulation Number866.5550
Classification Product Code
DEH  
Date Received05/03/1993
Decision Date 06/13/1994
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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