Albumin BCP2— 510(k) K203530

Name: FDA 510(k) clearance K203530
Creator: U.S. Food and Drug Administration
Published: 2022-03-18

Substantially Equivalent

Abbott Ireland Diagnostics Division

FDA 510(k) clearance K203530 for Albumin BCP2, Substantially Equivalent on 2022-03-18. Applicant: Abbott Ireland Diagnostics Division. Device class: 2.

Clearance details

Applicant: Abbott Ireland Diagnostics Division
Product code: Code CJW
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 2020-12-02
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longford, IE

Download summary PDF View on FDA.gov ↗

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K193001 — Albumin BCP2019-12-19
K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR2013-10-16
K021636 — ALBUMIN REAGENT2002-07-17
K000483 — RANDOX ALBUMIN2000-03-31
K990978 — ALBUMIN BCG, MODEL AL 103-011999-05-25

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