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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Cytomegalovirus
510(k) Number K852929
Device Name CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
Applicant
Microbix Biosystems, Inc.
341 Bering Ave.
Toronto, Ontario M9a 4x3
Canada,  CA
Applicant Contact WILLIAM J GASTLE
Correspondent
Microbix Biosystems, Inc.
341 Bering Ave.
Toronto, Ontario M9a 4x3
Canada,  CA
Correspondent Contact WILLIAM J GASTLE
Regulation Number866.3175
Classification Product Code
GQI  
Date Received07/09/1985
Decision Date 11/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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