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519
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489
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431
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403
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400
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386
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Manufacturers
IL
Bioview , Ltd.
Medical Device Manufacturer
·
IL , Ra'Ananna
Bioview , Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2003
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bioview , Ltd.
Hematology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 23, 2007
DUET SYSTEM
K061602
·
JOY
Hematology
·
229d
Cleared
Aug 16, 2005
MODIFICATION TO DUET SYSTEM
K050840
·
JOY
Hematology
·
137d
Cleared
Sep 16, 2004
DUET SYSTEM
K040591
·
JOY
Hematology
·
192d
Cleared
Aug 20, 2003
DUET SYSTEM
K030192
·
JOY
Hematology
·
211d
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5
Hematology
4
Pathology
1