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Manufacturers
US
Abtox, Inc.
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Medical Device Manufacturer
·
US , Mundelein , IL
Abtox, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1994
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abtox, Inc.
General Hospital
✕
3
devices
1-3 of 3
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Cleared
Dec 22, 1994
PLAZLYTE(TM)
K905119
·
FLF
General Hospital
·
1499d
Cleared
Dec 22, 1994
ABTOX PLAZLYTE PROCESS MONITOR
K923442
·
FLF
General Hospital
·
892d
Cleared
Dec 22, 1994
ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR
K923739
·
FRC
General Hospital
·
878d
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3
General Hospital
3