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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K111822
Device Name STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
Applicant
Diagnostica Stago, Inc.
Piazza Albania 10
Rome,  IT 00153
Applicant Contact CARLO D'ALESSANDRO
Correspondent
Diagnostica Stago, Inc.
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact CARLO D'ALESSANDRO
Regulation Number864.7525
Classification Product Code
KFF  
Subsequent Product Codes
GGN   JIS  
Date Received06/28/2011
Decision Date 10/26/2011
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
Recalls CDRH Recalls
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