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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Fibrinogen Determination
510(k) Number K050928
Device Name DADE THROMBIN REAGENT
Applicant
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500 M.S. 514; Pox 6101
Newark,  DE  19714
Applicant Contact KATHELEEN A DRAY-LYONS
Correspondent
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500 M.S. 514; Pox 6101
Newark,  DE  19714
Correspondent Contact KATHELEEN A DRAY-LYONS
Regulation Number864.7340
Classification Product Code
KQJ  
Date Received04/14/2005
Decision Date 06/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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