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510(k) K072288

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

K072288 is an FDA 510(k) premarket notification submitted by Mitsubishi Kagaku Iatron for the device "PATHFAST D-DIMER". The FDA issued a decision of Substantially Equivalent on May 6, 2009. The device falls under product code GHH (Fibrin Split Products), a Class II device regulated under 21 CFR 864.7320. Mitsubishi Kagaku Iatron has at least 3 other 510(k) clearances on record.

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)

Other clearances for product code GHH

  • K112120 — DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET (January 24, 2013)
  • 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)

FDA data resources