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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 K881247
Device Name MONO-PHILE
Applicant
Bio Diagnostic Systems, Inc.
1 Wall St.
Princeton,  NJ  08540
Applicant Contact BERNARD FISHBEIN
Correspondent
Bio Diagnostic Systems, Inc.
1 Wall St.
Princeton,  NJ  08540
Correspondent Contact BERNARD FISHBEIN
Regulation Number866.5640
Classification Product Code
KTN  
Date Received03/23/1988
Decision Date 04/07/1988
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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