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CHN

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Immunochemical, Ceruloplasmin
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5210
Medical specialty
Immunology
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RecordFirmDate
TINA-QUANT CERULOPLASMIN (K091741)Roche Diagnostics2010-03-18
DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH (K063655)Dade Behring, Inc.2007-02-15
CERULOPLASMIN, MODEL 2055953 (K062114)Roche Diagnostics Corp.2007-01-31

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