510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051456Substantially Equivalent

Sentinel Ceruloplasmin

Sentinel CH SpA, Milano, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051456 is the FDA 510(k) clearance record for SENTINEL CERULOPLASMIN, a class II device, cleared for Sentinel Ch. Srl on under FDA product code JFR (Indirect Copper Assay, Ceruloplasmin). FDA records list 22 510(k) clearances for Sentinel Ch. Srl, from to . As of , FDA records show no recalls naming K051456.

Clearance record

Decision date
Received
(141 days to decision)
Product code
JFR Indirect Copper Assay, Ceruloplasmin
Regulation
21 CFR 866.5210
Device class
Class II
Review panel
Immunology
Applicant
Sentinel Ch. Srl 5 Via Principe Eugenio, Milano, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JFR

Trailing 12 months

FDA records hold no clearances under product code JFR in the trailing twelve months.

FDA records show no clearances under product code JFR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260