ABL90 FLEX SERIES— 510(k) K092686

Clearance details

Applicant

Radiometer Medical Aps

Product code

Code CEM

Device class

Class 2

Regulation

21 CFR 862.1600

Advisory panel

Clinical Chemistry

Date received

2009-09-02

Decision date

2010-08-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bronshoj, DK

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092686.