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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, If, Toxoplasma Gondii
510(k) Number K844287
Device Name ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII
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 Number866.3780
Classification Product Code
GLZ  
Date Received11/05/1984
Decision Date 01/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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