Cleared Traditional

RAPIDPOINT 405 NEONATAL BILIRUBIN

K110277 · Siemens Healthcare Diagnostics · Chemistry
Aug 2011
Decision
196d
Days
Class 1
Risk

About This 510(k) Submission

K110277 is an FDA 510(k) clearance for the RAPIDPOINT 405 NEONATAL BILIRUBIN, a Bilirubin (total And Unbound) In The Neonate Test System (Class I — General Controls, product code MQM), submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on August 15, 2011, 196 days after receiving the submission on January 31, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1113.

Submission Details

510(k) Number K110277 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2011
Decision Date August 15, 2011
Days to Decision 196 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

Similar Devices — MQM Bilirubin (total And Unbound) In The Neonate Test System

All 16
ABL90 FLEX, ABL90 FLEX PLUS
K170882 · Radiometer Medical Aps · Apr 2017
ABL90 FLEX
K132691 · Radiometer Medical Aps · Nov 2014
DRAEGER JAUNDICE METER JM-105
K133175 · Draeger Medical Systems, Inc. · Nov 2014
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
K073537 · Siemens Medical Solutions Diagnostics · Jun 2008
JAUNDICE METER, MODEL JM 103
K042522 · Draeger Medical Infant Care, Inc. · Jul 2005
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174 · Roche Diagnostics Corp. · May 2004

More from Siemens Healthcare Diagnostics

View all
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
K243570 · JLW · Apr 2025
ADVIA 2120i, ADVIA 2120
K162977 · GKZ · Aug 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · MRG · Mar 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
K161954 · JGS · Mar 2017
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
K162538 · JIT · Nov 2016