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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

K070453 is an FDA 510(k) premarket notification submitted by Olympus Life & Material Science Europa GmbH (Irish for the device "OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL". The FDA issued a decision of Substantially Equivalent on June 11, 2007. The device falls under product code GHH (Fibrin Split Products), a Class II device regulated under 21 CFR 864.7320. Olympus Life & Material Science Europa GmbH (Irish has at least 2 other 510(k) clearances on record.

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)

FDA data resources