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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, (Chlamydiae Group)
510(k) Number K900973
Device Name VISUWELL(R) CHLAMYDIA
Applicant
Adi Diagnostics, Inc.
30 Meridian Rd.
Rexdale, Ontario,  CA M9W 4Z7
Applicant Contact JANET SHAW
Correspondent
Adi Diagnostics, Inc.
30 Meridian Rd.
Rexdale, Ontario,  CA M9W 4Z7
Correspondent Contact JANET SHAW
Regulation Number866.3120
Classification Product Code
LJC  
Date Received03/02/1990
Decision Date 05/15/1990
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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