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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 K922726
Device Name TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL
Applicant
Simplicity Diagnostics, Inc.
P.O. Box 730
21 N. York Rd.
Hatboro,  PA  19040
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Simplicity Diagnostics, Inc.
P.O. Box 730
21 N. York Rd.
Hatboro,  PA  19040
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number866.5640
Classification Product Code
KTN  
Date Received06/05/1992
Decision Date 10/05/1992
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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