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Manufacturers
GB
Axis-Shield , Ltd.
Medical Device Manufacturer
·
GB , Dundee
Axis-Shield , Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2000
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Axis-Shield , Ltd.
Immunology
✕
1
devices
1-1 of 1
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Cleared
Aug 21, 2000
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
K001981
·
MID
Immunology
·
53d
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2
Immunology
1
Toxicology
1