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JFR

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Indirect Copper Assay, Ceruloplasmin
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5210
Medical specialty
Immunology
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RecordFirmDate
SENTINEL CERULOPLASMIN (K051456)Sentinel Ch. Srl2005-10-21
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM (K882622)Technicon Instruments Corp.1988-07-08

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Every clearance here is in the API, with alerts when new ones post.