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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K900338
Device Name VISUWELL(R) REAGIN TEST (MODIFICATION)
Applicant
Adi Diagnostics, Inc.
30 Meridian Rd.
Rexdale, Ontario,  CA M9W 4Z7
Applicant Contact SHAW
Correspondent
Adi Diagnostics, Inc.
30 Meridian Rd.
Rexdale, Ontario,  CA M9W 4Z7
Correspondent Contact SHAW
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received01/23/1990
Decision Date 04/10/1990
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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