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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Russel Viper Venom
510(k) Number K061805
Device Name STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
Applicant
Diagnostica Stago, Inc.
5 Century Dr.
Parisppany,  NJ  07054
Applicant Contact LAURA WORFOLK
Correspondent
Diagnostica Stago, Inc.
5 Century Dr.
Parisppany,  NJ  07054
Correspondent Contact LAURA WORFOLK
Regulation Number864.8950
Classification Product Code
GIR  
Date Received06/27/2006
Decision Date 12/06/2006
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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