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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K013155
Device Name DADE THROMBOPLASTIN C PLUS
Applicant
Dade Behring, Inc.
13251 NW 9th Terrace
Miami,  FL  33182
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
13251 NW 9th Terrace
Miami,  FL  33182
Correspondent Contact RADAMES RIESGO
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/21/2001
Decision Date 01/18/2002
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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