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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 (Enzyme-Labeled), Antigen, Controls
510(k) Number K843745
Device Name ADP ANA APPLEZYME
Applicant
Apple Diagnostic Products
P.O. Box 216
Pipersille,  PA  18942
Applicant Contact RAJ IRUKULLA
Correspondent
Apple Diagnostic Products
P.O. Box 216
Pipersille,  PA  18942
Correspondent Contact RAJ IRUKULLA
Regulation Number866.5100
Classification Product Code
LJM  
Date Received09/25/1984
Decision Date 10/25/1984
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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