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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 K880148
Device Name INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST
Applicant
Ampcor, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Applicant Contact RAYMOND GOULD
Correspondent
Ampcor, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Correspondent Contact RAYMOND GOULD
Regulation Number866.5640
Classification Product Code
KTN  
Date Received01/13/1988
Decision Date 02/10/1988
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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