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FDA 510(k) Application Details - K212183
Device Classification Name
System, Multipurpose For In Vitro Coagulation Studies
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510(K) Number
K212183
Device Name
System, Multipurpose For In Vitro Coagulation Studies
Applicant
Diagnostica Stago SAS
3 allΘe ThΘrΘsa
AsniΘres sur Seine 92600 FR
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Contact
Pauline Vasselon
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Regulation Number
864.5425
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Classification Product Code
JPA
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More FDA Info for this Product Code
Date Received
07/13/2021
Decision Date
06/07/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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