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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 K920221
Device Name HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY
Applicant
Akers Research Corp.
201 Grove Rd., Suite #1
Thorofare,  NJ  08086
Applicant Contact AKERS, JR.
Correspondent
Akers Research Corp.
201 Grove Rd., Suite #1
Thorofare,  NJ  08086
Correspondent Contact AKERS, JR.
Regulation Number866.5640
Classification Product Code
KTN  
Date Received01/16/1992
Decision Date 03/13/1992
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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