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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Hai (Including Hai Control), Rubella
510(k) Number K771957
Device Name RUBELLA HEMAGGLUTINATION REAGENT KIT
Applicant
Flow Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Flow Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3510
Classification Product Code
GOK  
Date Received10/17/1977
Decision Date 10/28/1977
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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