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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K993291
Device Name COPALIS RUBELLA IGM
Applicant
DiaSorin, Inc.
9175 Guiford Rd.
Columbia,  MD  21046
Applicant Contact JUDITH J SMITH
Correspondent
DiaSorin, Inc.
9175 Guiford Rd.
Columbia,  MD  21046
Correspondent Contact JUDITH J SMITH
Regulation Number866.3510
Classification Product Code
LFX  
Date Received10/01/1999
Decision Date 02/10/2000
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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