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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K253658
Device Name STA Satellite Max®
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 Number864.5425
Classification Product Code
JPA  
Subsequent Product Codes
DAP   GGW   GJS   KFF   KQJ  
Date Received11/20/2025
Decision Date 04/27/2026
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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