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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 K010963
Device Name STA-LIATEST FREE PROTEIN S TEST KIT
Applicant
Diagnostica Stago, Inc.
5 Century Dr.
Parisppany,  NJ  07054
Applicant Contact ANDREW LOC B LE
Correspondent
Diagnostica Stago, Inc.
5 Century Dr.
Parisppany,  NJ  07054
Correspondent Contact ANDREW LOC B LE
Regulation Number864.7290
Classification Product Code
GGP  
Date Received03/30/2001
Decision Date 06/06/2001
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
Recalls CDRH Recalls
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