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533
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519
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489
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447
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403
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400
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387
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Manufacturers
US
Wako Chemicals USA, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Wako Chemicals USA, Inc. - FDA 510(k) Cleared Devices
124 submissions
·
123 cleared
·
Since 1981
124
Total
123
Cleared
1
Denied
30
devices
26-30 of 30
Filters
1
2
Cleared
Jul 28, 1992
WAKO AUTOKIT RF
K922151
·
DHR
Immunology
·
82d
Cleared
Jul 08, 1988
WAKO(TM) CRP
K882374
·
DCN
Immunology
·
29d
Cleared
Jun 06, 1988
WAKO(TM) IGG-HA DIRECT
K880784
·
DEW
Immunology
·
101d
Cleared
Mar 29, 1988
WAKO(TM) IGA-HA DIRECT
K880803
·
CZP
Immunology
·
29d
Cleared
Mar 25, 1988
WAKO(TM) IGM-HA DIRECT
K880828
·
DFT
Immunology
·
24d
1
2
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124
Chemistry
89
Immunology
30
Pathology
2
Toxicology
2
Hematology
1