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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 K001067
Device Name DADE BEHRING COAGULATION ANALYZER (BCT)
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number864.5425
Classification Product Code
JPA  
Subsequent Product Code
KQJ  
Date Received04/03/2000
Decision Date 06/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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