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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen Standard
510(k) Number K072304
Device Name FIBRINOGEN CALIBRATOR KIT
Applicant
Dade Behring, Inc.
P.O. Box 6101; Ms 514
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
P.O. Box 6101; Ms 514
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Correspondent Contact RADAMES RIESGO
Regulation Number864.7340
Classification Product Code
GFX  
Date Received08/17/2007
Decision Date 09/19/2007
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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