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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 K042272
Device Name ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
Applicant
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact EDWARD TUNG, PH.D.
Correspondent
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact EDWARD TUNG, PH.D.
Regulation Number866.5640
Classification Product Code
KTN  
Date Received08/23/2004
Decision Date 02/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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