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Manufacturers
US
Bioware Products
Medical Device Manufacturer
·
US , Mchenry , IL
Bioware Products - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1980
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bioware Products
Immunology
✕
2
devices
1-2 of 2
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Cleared
Jan 29, 1981
K/K (ASMA/ANA) UNIVERSAL BIOPAK
K802299
·
DHN
Immunology
·
132d
Cleared
Dec 01, 1980
T/K (ATA/AMA) UNIVERSAL BIOPAK
K802308
·
DBM
Immunology
·
69d
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4
Immunology
2
Microbiology
1
Chemistry
1