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510(k) K912025

SPECTROLYSE PLASMINOGEN SK KIT by Biopool AB — Product Code GGP

K912025 is an FDA 510(k) premarket notification submitted by Biopool AB for the device "SPECTROLYSE PLASMINOGEN SK KIT". The FDA issued a decision of Substantially Equivalent on August 22, 1991. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Biopool AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1991
Date Received
May 7, 1991
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)
  • K902530 — SPECTROLYSE ATIII KIT (August 9, 1990)

Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • 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)

FDA data resources