Ceruloplasmin— 510(k) K161508

Substantially Equivalent

Beckman Coulter Ireland, Inc.

FDA 510(k) clearance K161508 for Ceruloplasmin, Substantially Equivalent on 2017-01-09. Applicant: Beckman Coulter Ireland, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter Ireland, Inc.
Product code: Code DDB
Device class: Class 2
Regulation: 21 CFR 866.5210
Advisory panel: Immunology
Date received: 2016-06-01
Decision date: 2017-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Co. Clare, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code DDB

K122965 — HUMAN CAERULOPLASMIN KIT2013-06-03
K053074 — N ANTISERA TO HUMAN CERULOPLASMIN2006-03-16
K964762 — IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT1997-04-25
K913668 — CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT1991-12-20
K895377 — QM300 CERULOPLASMIN ANTIBODY PACK1989-09-21

More clearances from Beckman Coulter Ireland, Inc.

K182651 — HbA1c Advanced2019-01-16
K161297 — Beta-2-Microglobulin2016-06-07
K142346 — Urine/CSF Albumin, Urine/CSF Albumin Calibrator2014-10-15
K141388 — SYSTEM CALIBRATER2014-07-11
K141374 — BICARBONATE CALIBRATOR2014-06-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.