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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Fluorescent, Rubeola
510(k) Number K770687
Device Name MEASLESVIRUS FLOURE. CONJUGATED ANTISERU
Applicant
Microbiological Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Microbiological Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3520
Classification Product Code
GRE  
Date Received04/13/1977
Decision Date 06/14/1977
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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