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510(k) K162227

STA® - Liatest® D-Di by Diagnostica Stago — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2016
Date Received
August 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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  • K112818 — VIDAS D-DIMER EXCLUSION II (DEX2) (July 31, 2012)
  • K110303 — STRATUS CS ACUTE CARE D-DIMER (May 16, 2011)
  • K093626 — INNOVANCE D-DIMER, MODEL OPBP09 (November 29, 2010)
  • K090264 — HEMOSIL D-DIMER HS 500, CONTROLS (February 5, 2010)
  • K091916 — INNOVANCE D-DIMER, MODEL OPBP09 (October 29, 2009)
  • K081732 — INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS (October 24, 2008)