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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 K931192
Device Name DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY
Applicant
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact KIM M KOSAI
Correspondent
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Correspondent Contact KIM M KOSAI
Regulation Number866.5550
Classification Product Code
DEH  
Date Received03/09/1993
Decision Date 04/20/1995
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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