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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Iha, Cytomegalovirus
510(k) Number K955799
Device Name COPALIS CMV TOTAL ANTIBODY ASSAY
Applicant
Sienna Biotech, Inc.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Applicant Contact JOYCE T DAVID
Correspondent
Sienna Biotech, Inc.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Correspondent Contact JOYCE T DAVID
Regulation Number866.3175
Classification Product Code
LJO  
Date Received12/22/1995
Decision Date 07/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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