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510(k) K013318

ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 by American Diagnostica, Inc. — Product Code KFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2002
Date Received
October 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by American Diagnostica, Inc.

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  • K052124 — ACTICLOT, MODEL 824 (October 17, 2005)
  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
  • K013492 — IMUBIND TPA ELISA, MODEL 860 (March 13, 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 KFF

  • K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
  • K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Hep (August 22, 2017)
  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
  • K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (June 2, 2009)
  • K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (May 24, 2006)
  • K013305 — ENOXAPARIN TEST CARD (August 23, 2002)
  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
  • K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (June 7, 2001)
  • K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (June 6, 2001)
  • K983178 — COAMATIC HEPARIN (November 3, 1998)