Cleared Traditional

DRAEGER JAUNDICE METER JM-105

K133175 · Draeger Medical Systems, Inc. · Chemistry
Nov 2014
Decision
392d
Days
Class 1
Risk

About This 510(k) Submission

K133175 is an FDA 510(k) clearance for the DRAEGER JAUNDICE METER JM-105, a Bilirubin (total And Unbound) In The Neonate Test System (Class I — General Controls, product code MQM), submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on November 13, 2014, 392 days after receiving the submission on October 17, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1113.

Submission Details

510(k) Number K133175 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2013
Decision Date November 13, 2014
Days to Decision 392 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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