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510(k) K923499

SPECTROLYSE HEPARIN KIT by Biopool AB — Product Code KFF

K923499 is an FDA 510(k) premarket notification submitted by Biopool AB for the device "SPECTROLYSE HEPARIN KIT". The FDA issued a decision of Substantially Equivalent on January 27, 1994. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Biopool AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
July 15, 1992
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 Biopool AB

  • K941752 — SPECTROLYSE ANTIPLASMIN KIT (September 25, 1995)
  • K942087 — BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES (July 13, 1995)
  • K934314 — TINTELIZER(R) TPA (February 23, 1994)
  • K932463 — BIOCLOT LA (September 27, 1993)
  • K920668 — MINUTEX D-DIMER LATEX TEST (October 16, 1992)
  • K922782 — SPECTROLYSE/PL PAI KIT (October 9, 1992)
  • K915163 — PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES (January 6, 1992)
  • K914307 — SPECTROLYSE PROTEIN C KIT (December 9, 1991)
  • K912025 — SPECTROLYSE PLASMINOGEN SK KIT (August 22, 1991)
  • K902530 — SPECTROLYSE ATIII KIT (August 9, 1990)

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