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DFG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Lambda, Rhodamine, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5550
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
TRUCATH.IP (K023368)Aortech Critical Care , Ltd.2002-10-28

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