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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, If, Toxoplasma Gondii
510(k) Number K861460
Device Name SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
Applicant
Widran Urological Group, Ltd.
111 N. Wabash Ave.
Chicago,  IL  60602
Applicant Contact JERROLD WIDRAN
Correspondent
Widran Urological Group, Ltd.
111 N. Wabash Ave.
Chicago,  IL  60602
Correspondent Contact JERROLD WIDRAN
Regulation Number866.3780
Classification Product Code
LJK  
Date Received04/18/1986
Decision Date 05/02/1986
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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