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510(k) K002948

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT by Kamiya Biomedical Co. — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2001
Date Received
September 21, 2000
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

Other clearances by Kamiya Biomedical Co.

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  • K093137 — K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (September 28, 2010)
  • K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (April 29, 2010)
  • K050944 — K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET (December 23, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C (June 27, 2003)
  • K023828 — K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULT (February 4, 2003)
  • K023853 — K-ASSAY LP(A) CONTROLS (December 13, 2002)
  • K022486 — K-ASSAY HS-CRP CONTROLS (August 14, 2002)

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)
  • K151534 — HemosIL D-Dimer HS (July 6, 2015)
  • 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)