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510(k) K042890

TRIAGE D-DIMER TEST, MODEL 98100 by Biosite Incorporated — Product Code GHH

K042890 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE D-DIMER TEST, MODEL 98100". The FDA issued a decision of Substantially Equivalent on November 29, 2004. The device falls under product code GHH (Fibrin Split Products), a Class II device regulated under 21 CFR 864.7320. Biosite Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2004
Date Received
October 19, 2004
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 Biosite Incorporated

  • K092987 — INRATIO/INRATIO2 TEST STRIPS (June 11, 2010)
  • K092048 — ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP (April 19, 2010)
  • K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET (November 13, 2009)
  • K080269 — TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (June 6, 2008)
  • K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 (December 7, 2007)
  • K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS (March 1, 2007)
  • K062530 — TRIAGE PROTEIN C TEST (January 29, 2007)
  • K060788 — TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (July 10, 2006)
  • K060791 — TRIAGE TOX DRUG SCREEN, MODEL 94400 (June 22, 2006)
  • K052789 — TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 (January 23, 2006)

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)
  • 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)
  • 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