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510k Database
Manufacturers
US
Bion Ent., Ltd.
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Medical Device Manufacturer
·
US , Mchenry , IL
Bion Ent., Ltd. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 1980
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bion Ent., Ltd.
Immunology
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1
devices
1-1 of 1
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Cleared
Aug 17, 1987
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
K872845
·
DHN
Immunology
·
28d
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14
Microbiology
12
Immunology
1
Radiology
1