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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Hai, Mumps Virus
510(k) Number K833077
Device Name WELLCOGEN H. INFLUENZAL ZL21
Applicant
Wellcome Diagnostics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Wellcome Diagnostics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3380
Classification Product Code
GRD  
Date Received09/09/1983
Decision Date 01/10/1984
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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