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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 K860493
Device Name CYTOTECH CMV IGG EIA
Applicant
Cytotech, Inc.
11035 Roselle St., Suite A
San Diego,  CA  92121
Applicant Contact TAMERIUS, PH.D.
Correspondent
Cytotech, Inc.
11035 Roselle St., Suite A
San Diego,  CA  92121
Correspondent Contact TAMERIUS, PH.D.
Regulation Number866.3175
Classification Product Code
GQI  
Date Received02/10/1986
Decision Date 05/20/1986
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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