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510(k) K072288

PATHFAST D-DIMER by Mitsubishi Kagaku Iatron — Product Code GHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2009
Date Received
August 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrin Split Products
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

Other clearances by Mitsubishi Kagaku Iatron

  • K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II (August 17, 2009)
  • K083412 — PATHFAST HSCRP (March 9, 2009)
  • K072189 — PATHFAST NTPROBNP AND D-DIMER TESTS (February 5, 2008)

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  • K070453 — OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR30 (June 11, 2007)
  • K062203 — TINA-QUANT D-DIMER TEST SYSTEM (March 14, 2007)
  • K042890 — TRIAGE D-DIMER TEST, MODEL 98100 (November 29, 2004)
  • K030740 — MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM (April 1, 2003)
  • K021877 — MDA D-DIMER (August 7, 2002)
  • K011143 — TINA-QUANT D-DIMER TEST SYSTEM (May 29, 2001)
  • K993276 — SIMPLIFY D-DIMER, MODEL DCGK1 (December 14, 1999)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K945642 — AGEN DIMERTEST GOLD EIA (October 25, 1995)