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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 K260214
Device Name STA® - Liquid Anti-Xa
Applicant
Diagnostica Stago, Inc.
Five Century Dr., Suite 200.
Parsippany,  NJ  07054
Applicant Contact Louise Sigismondi
Correspondent
Diagnostica Stago, Inc.
Five Century Dr., Suite 200.
Parsippany,  NJ  07054
Correspondent Contact Louise Sigismondi
Regulation Number864.7525
Classification Product Code
KFF  
Subsequent Product Codes
GGN   JIS  
Date Received01/23/2026
Decision Date 09/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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