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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K855053
Device Name THABEST-IGE
Applicant
Visual Diagnostics, Inc.
190 W. Englewood Ave.
Teaneck,  NJ  07666
Applicant Contact MADHAVA RAMANARAYANA
Correspondent
Visual Diagnostics, Inc.
190 W. Englewood Ave.
Teaneck,  NJ  07666
Correspondent Contact MADHAVA RAMANARAYANA
Regulation Number866.5750
Classification Product Code
DHB  
Date Received12/17/1985
Decision Date 04/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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