SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS— 510(k) K071277

Name: FDA 510(k) clearance K071277
Creator: U.S. Food and Drug Administration
Published: 2007-06-01

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K071277 for SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS, Substantially Equivalent on 2007-06-01. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2007-05-07
Decision date: 2007-06-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K071277

K-number listed on FDA's recall record

Z-2730-2017 — Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.Class II·Terminated·Beckman Coulter Inc·20170515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071277.

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