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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 K992763
Device Name SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
Applicant
Dade Behring, Inc.
1851 Delaware Pkwy.
Miami,  FL  33125
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
1851 Delaware Pkwy.
Miami,  FL  33125
Correspondent Contact RADAMES RIESGO
Regulation Number864.5400
Classification Product Code
GKP  
Subsequent Product Code
JPA  
Date Received08/17/1999
Decision Date 09/21/1999
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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