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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antigen, cf (including cf control), cytomegalovirus
510(k) Number K880679
Device Name BION CMV-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 Number866.3175
Classification Product Code
GQH  
Date Received02/19/1988
Decision Date 06/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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