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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Herpesvirus Hominis 1,2
510(k) Number K881261
Device Name BION HSV1-G OR HSV2-G TEST SYSTEM
Applicant
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Applicant Contact EDWARD NOWAKOWSKI
Correspondent
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Correspondent Contact EDWARD NOWAKOWSKI
Regulation Number866.3305
Classification Product Code
GQO  
Date Received03/24/1988
Decision Date 06/07/1988
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
Recalls CDRH Recalls
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