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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K013114
Device Name BCS SYSTEM
Applicant
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number864.5425
Classification Product Code
JPA  
Subsequent Product Codes
GGP   GIR  
Date Received09/18/2001
Decision Date 11/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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