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Manufacturers
US
Inbios Intl., Inc.
Medical Device Manufacturer
·
US , Seattle , WA
Inbios Intl., Inc. - FDA 510(k) Cleared Devices
6 submissions
·
5 cleared
·
Since 1999
6
Total
5
Cleared
1
Denied
FDA 510(k) Regulatory Record - Inbios Intl., Inc.
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 26, 2000
GENERIC BLOOD GLUCOSE TEST STRIP
K001092
·
CGA
Chemistry
·
113d
Cleared
Oct 18, 1999
INSURE PRO TEST
K992695
·
JHI
Chemistry
·
68d
Cleared
May 28, 1999
INSURE PREGNANCY TEST
K991515
·
DHA
Chemistry
·
28d
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Microbiology
3
Chemistry
3