510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161508Substantially Equivalent

Ceruloplasmin

Beckman Coulter Ireland Inc, Co. Clare, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161508 is the FDA 510(k) clearance record for Ceruloplasmin, a class II device, cleared for Beckman Coulter Ireland, Inc. on under FDA product code DDB (Ceruloplasmin, Antigen, Antiserum, Control). FDA records list 7 510(k) clearances for Beckman Coulter Ireland, Inc., from to . As of , FDA records show no recalls naming K161508.

Clearance record

Decision date
Received
(222 days to decision)
Product code
DDB Ceruloplasmin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5210
Device class
Class II
Review panel
Immunology
Applicant
Beckman Coulter Ireland, Inc. Lismeehan, Co. Clare, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DDB

Trailing 12 months

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

FDA records show no clearances under product code DDB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DDB, 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