510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JFRClass II

Indirect Copper Assay, Ceruloplasmin

21 CFR 866.5210 / Immunology
FDA source (opens on fda.gov)

JFR is the FDA product code for Indirect Copper Assay, Ceruloplasmin, a class II device type, regulated under 21 CFR 866.5210. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JFR
Device name
Indirect Copper Assay, Ceruloplasmin
Regulation
21 CFR 866.5210
Device class
Class II
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code JFR

By decision year
2 clearances under product code JFR with a decision year between 1988 and 2005, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JFR by decision year
YearClearances
19881
20051

Applicants with the most clearances

Product code JFR
Applicants holding the most 510(k) clearances under product code JFR
ApplicantClearances
Sentinel CH SpA1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code