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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Iha, Cytomegalovirus
510(k) Number K920222
Device Name HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS
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 Number866.3175
Classification Product Code
LJO  
Date Received01/16/1992
Decision Date 07/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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