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459
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314
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288
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Manufacturers
US
Bionime Coporation
Medical Device Manufacturer
·
US , Mission Viejo , CA
Bionime Coporation - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bionime Coporation
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 09, 2015
Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose...
K141292
·
NBW
Chemistry
·
386d
Cleared
Jun 03, 2015
GE333 Blood Glucose Monitoring System
K143387
·
NBW
Chemistry
·
189d
Cleared
Apr 17, 2014
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED...
K133522
·
NBW
Chemistry
·
153d
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3
Chemistry
3