Biopool AB - FDA 510(k) Cleared Devices
13
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biopool AB Hematology ✕
13 devices
Cleared
Sep 25, 1995
SPECTROLYSE ANTIPLASMIN KIT
Hematology
535d
Cleared
Jul 13, 1995
BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES
Hematology
437d
Cleared
Feb 23, 1994
TINTELIZER(R) TPA
Hematology
175d
Cleared
Jan 27, 1994
SPECTROLYSE HEPARIN KIT
Hematology
561d
Cleared
Sep 27, 1993
BIOCLOT LA
Hematology
129d
Cleared
Oct 16, 1992
MINUTEX D-DIMER LATEX TEST
Hematology
246d
Cleared
Oct 09, 1992
SPECTROLYSE/PL PAI KIT
Hematology
122d
Cleared
Jan 06, 1992
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
Hematology
53d
Cleared
Dec 09, 1991
SPECTROLYSE PROTEIN C KIT
Hematology
75d
Cleared
Aug 22, 1991
SPECTROLYSE PLASMINOGEN SK KIT
Hematology
107d
Cleared
Aug 09, 1990
BIOCLOT C KIT
Hematology
65d
Cleared
Aug 09, 1990
SPECTROLYSE ATIII KIT
Hematology
65d
Cleared
Aug 09, 1990
BIOPOOL PROTEIN C EID KIT AND BULK PLATES
Hematology
59d