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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K000649
Device Name SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
Applicant
Dade Behring, Inc.
7739 NW 48 St.
Suite 120
Miami,  FL  33166
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
7739 NW 48 St.
Suite 120
Miami,  FL  33166
Correspondent Contact RADAMES RIESGO
Regulation Number864.7290
Classification Product Code
GGP  
Subsequent Product Code
KFF  
Date Received02/28/2000
Decision Date 04/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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