Cleared Traditional

ABL90 FLEX, ABL90 FLEX PLUS

K170882 · Radiometer Medical Aps · Chemistry
Apr 2017
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K170882 is an FDA 510(k) clearance for the ABL90 FLEX, ABL90 FLEX PLUS, a Bilirubin (total And Unbound) In The Neonate Test System (Class I — General Controls, product code MQM), submitted by Radiometer Medical Aps (Broenshoej, DK). The FDA issued a Cleared decision on April 28, 2017, 35 days after receiving the submission on March 24, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1113.

Submission Details

510(k) Number K170882 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2017
Decision Date April 28, 2017
Days to Decision 35 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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