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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, Epstein-Barr Virus
510(k) Number K891785
Device Name BION EBV-G (VCA) TEST SYSTEM
Applicant
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Applicant Contact EDWARD NORWAKOWSKI
Correspondent
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Correspondent Contact EDWARD NORWAKOWSKI
Regulation Number866.3235
Classification Product Code
JRY  
Date Received03/24/1989
Decision Date 08/31/1989
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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