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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 K994341
Device Name FIBRINOGEN CALIBRATOR KIT
Applicant
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714
Applicant Contact REBECCA S AYASH
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714
Correspondent Contact REBECCA S AYASH
Regulation Number864.7340
Classification Product Code
GFX  
Date Received12/23/1999
Decision Date 03/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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