MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)— 510(k) K014034

Name: FDA 510(k) clearance K014034
Creator: U.S. Food and Drug Administration
Published: 2001-12-18

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K014034 for MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO), Substantially Equivalent on 2001-12-18. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JFL
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2001-12-07
Decision date: 2001-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFL

view all

K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System2020-02-07
K040975 — GENCHEM CO2 ACID REAGENT2004-12-27
K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT1996-10-24
K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER1996-10-11
K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER1996-09-27

More clearances from Beckman Coulter, Inc.

view all

K252169 — Access BNP II2026-03-24
K254059 — Access anti-HBc IgM2026-03-13
K253687 — Access anti-HBc Total2026-02-19
K251995 — Access anti-HAV IgM2026-01-27
K250588 — Access Rubella IgG2025-11-17

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