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510k Database
Manufacturers
US
Ikonisys, Inc.
Medical Device Manufacturer
·
US , New Haven , CT
Ikonisys, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ikonisys, Inc.
Hematology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 04, 2007
IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
K062755
·
JOY
Hematology
·
112d
Cleared
Aug 01, 2006
IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
K061392
·
JOY
Hematology
·
74d
Cleared
Jan 24, 2006
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
K052577
·
JOY
Hematology
·
127d
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4
Hematology
3
Pathology
1