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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 K870732
Device Name RAT LIVER NUCLEI TEST SYSTEM
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 Received02/25/1987
Decision Date 03/10/1987
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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