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Manufacturers
US
Haemachem, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Haemachem, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1984
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Haemachem, Inc.
Hematology
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 14, 1991
FIBRINOTEST(TM) - FIBRINOGEN ASSAY
K903874
·
GIS
Hematology
·
176d
Cleared
Nov 05, 1985
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
K853239
·
KFF
Hematology
·
96d
Cleared
Jul 19, 1984
BOVINE THROMBIN, HUMAN THROMBIN
K841956
·
GJA
Hematology
·
66d
Cleared
Jul 19, 1984
BOVINE FACTOR XA-HUMAN FACTOR XA
K841957
·
GGP
Hematology
·
66d
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Hematology
4