SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100— 510(k) K082251

Name: FDA 510(k) clearance K082251
Creator: U.S. Food and Drug Administration
Published: 2009-04-08

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K082251 for SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100, Substantially Equivalent on 2009-04-08. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 2008-08-08
Decision date: 2009-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K082251

K-number listed on FDA's recall record

Z-2124-2017 — Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urineClass II·Terminated·Beckman Coulter Inc.·20170424

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082251.

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