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510(k) K151867

STA R MAX by Diagnostica Stago S.A.S — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2015
Date Received
July 9, 2015
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

Other clearances by Diagnostica Stago S.A.S

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  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
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  • K092170 — STA LIATEST FREE PS (December 22, 2009)
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  • K092113 — STA - FREE PS CALIBRATOR (November 13, 2009)

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  • K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (A (December 29, 2021)
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