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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K031377
Device Name SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
Applicant
Dade Behring, Inc.
500 Gbc Dr.
Newark,  DE  19702
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
500 Gbc Dr.
Newark,  DE  19702
Correspondent Contact RADAMES RIESGO
Regulation Number864.5400
Classification Product Code
GKP  
Date Received05/01/2003
Decision Date 09/08/2003
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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