Cleared Traditional

ABL90 FLEX SERIES

K092686 · Radiometer Medical Aps · Chemistry
Aug 2010
Decision
338d
Days
Class 2
Risk

About This 510(k) Submission

K092686 is an FDA 510(k) clearance for the ABL90 FLEX SERIES, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on August 6, 2010, 338 days after receiving the submission on September 2, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K092686 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2009
Decision Date August 06, 2010
Days to Decision 338 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEM — Electrode, Ion Specific, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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