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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Conjugated Fluorescent, Cytomegalovirus
510(k) Number K860279
Device Name CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
Applicant
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact HOWARD TAYLOR
Correspondent
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact HOWARD TAYLOR
Regulation Number866.3175
Classification Product Code
LIN  
Date Received01/14/1986
Decision Date 05/13/1986
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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