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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plasminogen, Antigen, Antiserum, Control
510(k) Number K884766
Device Name BERICHROM(R) PLASMINOGEN
Applicant
BEHRING DIAGNOSTICS, INC.
17 CHUBB WAY
SOMERVILLE,  NJ  08876
Applicant Contact JOHN E HUGHES
Correspondent
BEHRING DIAGNOSTICS, INC.
17 CHUBB WAY
SOMERVILLE,  NJ  08876
Correspondent Contact JOHN E HUGHES
Regulation Number866.5715
Classification Product Code
DDX  
Date Received11/14/1988
Decision Date 01/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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