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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Infectious Mononucleosis
510(k) Number K844289
Device Name SERIES I/S INFECTIONS
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact JAMES E KELLER
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact JAMES E KELLER
Regulation Number866.5640
Classification Product Code
KTN  
Date Received11/05/1984
Decision Date 11/19/1984
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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