Cleared Traditional

ABL90 FLEX

K132691 · Radiometer Medical Aps · Chemistry
Nov 2014
Decision
442d
Days
Class 1
Risk

About This 510(k) Submission

K132691 is an FDA 510(k) clearance for the ABL90 FLEX, a Bilirubin (total And Unbound) In The Neonate Test System (Class I — General Controls, product code MQM), submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on November 13, 2014, 442 days after receiving the submission on August 28, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1113.

Submission Details

510(k) Number K132691 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2013
Decision Date November 13, 2014
Days to Decision 442 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MQM — Bilirubin (total And Unbound) In The Neonate Test System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1113

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