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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antinuclear antibody, indirect immunofluorescent, antigen, control
510(k) Number K871395
Device Name DUAL SUBSTRATE ANA
Applicant
VAL TECH DIAGNOSTICS, INC.
14 WERNER CAMP RD.
pittsburgh,  PA  15215
Applicant Contact steve l sinka
Correspondent
VAL TECH DIAGNOSTICS, INC.
14 WERNER CAMP RD.
pittsburgh,  PA  15215
Correspondent Contact steve l sinka
Regulation Number866.5100
Classification Product Code
DHN  
Date Received04/07/1987
Decision Date 04/20/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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