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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 K910487
Device Name VISUWELL SYPHILIS ANTIGEN
Applicant
Adi Diagnostics, Inc.
30 Meridian Rd.
Rexdale, Ontario,  CA M9W 4Z7
Applicant Contact HEATHER SMITH
Correspondent
Adi Diagnostics, Inc.
30 Meridian Rd.
Rexdale, Ontario,  CA M9W 4Z7
Correspondent Contact HEATHER SMITH
Regulation Number866.3830
Classification Product Code
LIP  
Date Received02/06/1991
Decision Date 06/24/1991
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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