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510(k) K093167

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER by Diagnostica Stago, Inc. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2009
Date Received
October 7, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K201440 — ROTEM sigma Thromboelastometry System (July 8, 2022)
  • K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (A (December 29, 2021)
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