Biopool AB

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K941752SPECTROLYSE ANTIPLASMIN KITSeptember 25, 1995
K942087BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATESJuly 13, 1995
K934314TINTELIZER(R) TPAFebruary 23, 1994
K923499SPECTROLYSE HEPARIN KITJanuary 27, 1994
K932463BIOCLOT LASeptember 27, 1993
K920668MINUTEX D-DIMER LATEX TESTOctober 16, 1992
K922782SPECTROLYSE/PL PAI KITOctober 9, 1992
K915163PROTEIN S EID KIT AND PROTEIN S EID BULK PLATESJanuary 6, 1992
K914307SPECTROLYSE PROTEIN C KITDecember 9, 1991
K912025SPECTROLYSE PLASMINOGEN SK KITAugust 22, 1991
K902530SPECTROLYSE ATIII KITAugust 9, 1990
K902528BIOCLOT C KITAugust 9, 1990
K902566BIOPOOL PROTEIN C EID KIT AND BULK PLATESAugust 9, 1990