Cleared Traditional

ABL8X7 FLEX

K051968 · Radiometer Medical Aps · Chemistry
Oct 2006
Decision
453d
Days
Class 2
Risk

About This 510(k) Submission

K051968 is an FDA 510(k) clearance for the ABL8X7 FLEX, a Electrode, Ion Based, Enzymatic, Creatinine (Class II — Special Controls, product code CGL), submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on October 16, 2006, 453 days after receiving the submission on July 20, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K051968 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2005
Decision Date October 16, 2006
Days to Decision 453 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGL — Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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