Biopool Vwf Eld Kit and Vwf Eld Bulk Plates

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K942087 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Minutex D-Dimer Latex Test

  Class II

  FDA 510(k) K920668 Active Cleared 16 Oct 1992

• Spectrolyse Atiii Kit

  Class II

  FDA 510(k) K902530 Active Cleared 9 Aug 1990

• Biopool Protein C Eid Kit and Bulk Plates

  Class II

  FDA 510(k) K902566 Active Cleared 9 Aug 1990

• Bioclot C Kit

  Class II

  FDA 510(k) K902528 Active Cleared 9 Aug 1990

• Protein S Eid Kit and Protein S Eid Bulk Plates

  Class II

  FDA 510(k) K915163 Active Cleared 6 Jan 1992

• Spectrolyse/Pl Pai Kit

  Class II

  FDA 510(k) K922782 Active Cleared 9 Oct 1992

See all devices from Biopool AB →