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JFR – Indirect Copper Assay, Ceruloplasmin
Indirect Copper Assay, Ceruloplasmin
FDA product code
JFR
· Class II (moderate risk) · 21 CFR 866.5210 ·
Immunology
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Technicon Instruments Corp.
1
SENTINEL CH. SpA
1
510(k) clearances
510(k)
Device
Applicant
Decision
K051456
Sentinel Ceruloplasmin
JFR · Traditional
Sentinel Ch. Srl
10/21/2005
SE
K882622
Ceruloplasmin for the Technicon DPA-1(TM) System
JFR · Traditional
Technicon Instruments Corp.
07/08/1988
SE