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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Ha (Including Ha Control), Rubella
510(k) Number K770092
Device Name HERPESIVIRUS TEST (TYPE L & 2)
Applicant
Microbiological Research Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Microbiological Research Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3510
Classification Product Code
GOL  
Date Received01/17/1977
Decision Date 03/01/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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