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510(k) K902566

BIOPOOL PROTEIN C EID KIT AND BULK PLATES by Biopool AB — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
June 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
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)
  • K923499 — SPECTROLYSE HEPARIN KIT (January 27, 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)

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  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)