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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K061803
Device Name STA - CONTROL LA 1+2
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 Number864.5425
Classification Product Code
GGC  
Subsequent Product Code
GGN  
Date Received06/27/2006
Decision Date 07/28/2006
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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