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510(k) K853239

HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY by Haemachem, Inc. — Product Code KFF

K853239 is an FDA 510(k) premarket notification submitted by Haemachem, Inc. for the device "HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY". The FDA issued a decision of Substantially Equivalent on November 5, 1985. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Haemachem, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1985
Date Received
August 1, 1985
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 Haemachem, Inc.

  • K903874 — FIBRINOTEST(TM) - FIBRINOGEN ASSAY (February 14, 1991)
  • K841956 — BOVINE THROMBIN, HUMAN THROMBIN (July 19, 1984)
  • K841957 — BOVINE FACTOR XA-HUMAN FACTOR XA (July 19, 1984)

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)
  • K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (March 8, 2002)
  • K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (June 7, 2001)
  • K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (June 6, 2001)

FDA data resources