ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX— 510(k) K043218

Clearance details

Applicant

Radiometer Medical Aps

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2004-11-22

Decision date

2005-05-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bronshoj, DK

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Death

20

Malfunction

999

Total

1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2303-2013 — Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.Class II·Terminated·Radiometer America Inc·20121008

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043218.