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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K883232
Device Name HISTONE REACTIVE 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
LLL  
Date Received08/01/1988
Decision Date 09/07/1988
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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