Albumin BCG2— 510(k) K203248

Name: FDA 510(k) clearance K203248
Creator: U.S. Food and Drug Administration
Published: 2021-11-23

Substantially Equivalent

Abbott Ireland Diagnostics Division

FDA 510(k) clearance K203248 for Albumin BCG2, Substantially Equivalent on 2021-11-23. Applicant: Abbott Ireland Diagnostics Division. Device class: 2.

Clearance details

Applicant: Abbott Ireland Diagnostics Division
Product code: Code CIX
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 2020-11-04
Decision date: 2021-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longford, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIX

view all

K251157 — Core Metabolic2026-01-09
K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin2021-09-21
K191316 — VITROS XT Chemistry Products ALB-TP Slides2019-06-07
K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA4002018-04-13
K131488 — ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT2013-08-19

More clearances from Abbott Ireland Diagnostics Division

view all

K223317 — Alkaline Phosphatase22023-07-21
K223324 — Total Bilirubin22022-12-29
K203597 — Cholesterol22022-06-30
K203771 — Urea Nitrogen22022-05-31
K210633 — Amylase22022-05-26

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