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510(k) K151534

HemosIL D-Dimer HS by Instrumentation Laboratory CO — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2015
Date Received
June 8, 2015
Clearance Type
Special
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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Other clearances for product code DAP

  • K172903 — HemosIL D-Dimer HS 500 (November 22, 2017)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K160885 — HemosIL D-Dimer HS (October 27, 2016)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • 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)