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510(k) K080069

DIMERTEST by American Diagnostica, Inc. — Product Code DAP

K080069 is an FDA 510(k) premarket notification submitted by American Diagnostica, Inc. for the device "DIMERTEST". The FDA issued a decision of Substantially Equivalent on February 13, 2008. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. American Diagnostica, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2008
Date Received
January 10, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

Other clearances by American Diagnostica, Inc.

  • K063323 — SPECTROLYSE PAI-1, MODEL 101201 (August 15, 2007)
  • K052124 — ACTICLOT, MODEL 824 (October 17, 2005)
  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
  • K013492 — IMUBIND TPA ELISA, MODEL 860 (March 13, 2002)
  • K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (March 8, 2002)
  • K013168 — IMUBIND PLASMA PAI-1 ELISA,MODEL 822 (March 7, 2002)
  • K012386 — ACTICLOT PROTEIN S, MODEL 843L (September 14, 2001)
  • K940490 — DV TEST AND DVV CONFIRM (April 5, 1995)
  • K935254 — DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (September 19, 1994)

Other clearances for product code DAP

  • K172903 — HemosIL D-Dimer HS 500 (November 22, 2017)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K160885 — HemosIL D-Dimer HS (October 27, 2016)
  • K151534 — HemosIL D-Dimer HS (July 6, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K112818 — VIDAS D-DIMER EXCLUSION II (DEX2) (July 31, 2012)
  • K110303 — STRATUS CS ACUTE CARE D-DIMER (May 16, 2011)
  • K093626 — INNOVANCE D-DIMER, MODEL OPBP09 (November 29, 2010)
  • K090264 — HEMOSIL D-DIMER HS 500, CONTROLS (February 5, 2010)
  • K091916 — INNOVANCE D-DIMER, MODEL OPBP09 (October 29, 2009)

FDA data resources