510(k) K170882

Device: ABL90 FLEX, ABL90 FLEX PLUS
Applicant: Radiometer Medical ApS
510(k) number: K170882
Product code: MQM
Decision: Substantially Equivalent (SESE)
Decision date: 2017-04-28
Date received: 2017-03-24
Regulation: 862.1113
Classification name: Bilirubin (total And Unbound) In The Neonate Test System
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K132691	ABL90 FLEX	Radiometer Medical Aps	2014-11-13
K133175	DRAEGER JAUNDICE METER JM-105	Draeger Medical Systems, Inc.	2014-11-13
K110277	RAPIDPOINT 405 NEONATAL BILIRUBIN	Siemens Healthcare Diagnostics	2011-08-15
K073537	NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265	Siemens Medical Solutions Diagnostics	2008-06-27
K042522	JAUNDICE METER, MODEL JM 103	Draeger Medical Infant Care, Inc.	2005-07-06
K040174	BILIRUBIN ASSAY ON THE OMNI S ANALYZER	Roche Diagnostics Corp.	2004-05-14
K021622	HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103	Hill-Rom Air-Shields	2003-04-01
K001687	COLORMATE TLC BILITEST SYSTEM	Chromatics Color Sciences Intl., Inc.	2001-09-13
K010052	RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER	Respironics, Inc.	2001-03-19
K994438	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	Spectrx, Inc.	2000-02-04
K983071	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	Respironics, Inc.	1999-03-04
K983134	NBIL	Abbott Laboratories	1998-09-23
K972309	JM-102 JAUNDICE METER	Air-Shields, Inc.	1998-09-22
K980646	IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES	Instrumentation Laboratory CO	1998-05-06
K964590	COLORMATE III	Chromatics Color Sciences Intl., Inc.	1997-07-24

summary

Decision Summary