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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Automated Platelet Aggregation
510(k) Number K060489
Device Name DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
Applicant
Dade Behring, Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
Bldg. 500 Mail Box 514
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact RADAMES RIESGO
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received02/24/2006
Decision Date 07/21/2006
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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