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510k Database
Manufacturers
IE
Abbott Ireland
Medical Device Manufacturer
·
IE , Lisnamuck
Abbott Ireland - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
Recent clearances:
Glucose2
,
Calcium2
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Ireland
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 24, 2025
Glucose2
K252357
·
CFR
Chemistry
·
87d
Cleared
Feb 10, 2025
Calcium2
K244042
·
CJY
Chemistry
·
42d
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2
Chemistry
2