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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 Immunoabsorption Assay, Treponema Pallidum
510(k) Number K932453
Device Name VISUWELL SYPHILIS ANTIBODY
Applicant
Biomira Diagnostics, Inc.
30 Meridian Rd.
Rexdale, Ontario,  CA M9W 4Z7
Applicant Contact ALTHEA R LAWRENCE
Correspondent
Biomira Diagnostics, Inc.
30 Meridian Rd.
Rexdale, Ontario,  CA M9W 4Z7
Correspondent Contact ALTHEA R LAWRENCE
Regulation Number866.3830
Classification Product Code
LIP  
Date Received05/20/1993
Decision Date 07/11/1995
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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