Home / 510(k) Clearances / K070453

510(k) K070453

OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL by Olympus Life & Material Science Europa GmbH (Irish — Product Code GHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2007
Date Received
February 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 Olympus Life & Material Science Europa GmbH (Irish

  • K070708 — OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR2 (August 21, 2007)
  • K070835 — OLYMPUS CK-MB REAGENT (June 4, 2007)

Other clearances for product code GHH

  • K112120 — DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET (January 24, 2013)
  • K072288 — PATHFAST D-DIMER (May 6, 2009)
  • 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)