SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298— 510(k) K093458

Name: FDA 510(k) clearance K093458
Creator: U.S. Food and Drug Administration
Published: 2009-12-04

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K093458 for SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298, Substantially Equivalent on 2009-12-04. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2009-11-06
Decision date: 2009-12-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K093458

K-number listed on FDA's recall record

Z-2080-2017 — Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.Class II·Terminated·Beckman Coulter Inc.·20170403

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093458.

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