Cleared Traditional

NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265

K073537 · Siemens Medical Solutions Diagnostics · Chemistry
Jun 2008
Decision
193d
Days
Class 1
Risk

About This 510(k) Submission

K073537 is an FDA 510(k) clearance for the NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265, a Bilirubin (total And Unbound) In The Neonate Test System (Class I — General Controls, product code MQM), submitted by Siemens Medical Solutions Diagnostics (Norowood, US). The FDA issued a Cleared decision on June 27, 2008, 193 days after receiving the submission on December 17, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1113.

Submission Details

510(k) Number K073537 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2007
Decision Date June 27, 2008
Days to Decision 193 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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