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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Agglutination Assay, Rubella
510(k) Number K970931
Device Name COPALIS TORC TOTAL ANTIBODY ASSAY
Applicant
Sienna Biotech, Inc.
9115 Guilford Rd., Suite 180
Columbia,  MD  21046
Applicant Contact JUDITH J SMITH
Correspondent
Sienna Biotech, Inc.
9115 Guilford Rd., Suite 180
Columbia,  MD  21046
Correspondent Contact JUDITH J SMITH
Regulation Number866.3510
Classification Product Code
LQN  
Date Received03/07/1997
Decision Date 04/24/1997
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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