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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 K212183
Device Name STA R Max 3, STA Compact Max 3
Applicant
Diagnostica Stago S.A.S
3 Allée Thérésa
Asniéres Sur Seine,  FR 92600
Applicant Contact Pauline Vasselon
Correspondent
Diagnostica Stago, Inc.
5 Century Dr.
Parisppany,  NJ  07054
Correspondent Contact Anthony Dennis
Regulation Number864.5425
Classification Product Code
JPA  
Date Received07/13/2021
Decision Date 06/07/2023
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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