FDA 510(k) Applications for Medical Device Product Code: MQM (Bilirubin (Total And Unbound) In The Neonate Test System)

FDA 510(k) Applications for Medical Device Product Code "MQM"
(Bilirubin (Total And Unbound) In The Neonate Test System)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K983134	ABBOTT LABORATORIES	NBIL	09/23/1998
K972309	AIR-SHIELDS, INC.	JM-102 JAUNDICE METER	09/22/1998
K964590	CHROMATICS COLOR SCIENCES INTL., INC.	COLORMATE III	07/24/1997
K001687	CHROMATICS COLOR SCIENCES INTL., INC.	COLORMATE TLC BILITEST SYSTEM	09/13/2001
K042522	DRAEGER MEDICAL INFANT CARE, INC.	JAUNDICE METER, MODEL JM 103	07/06/2005
K133175	DRAEGER MEDICAL SYSTEMS, INC.	DRAEGER JAUNDICE METER JM-105	11/13/2014
K021622	HILL-ROM AIR-SHIELDS	HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103	04/01/2003
K980646	INSTRUMENTATION LABORATORY CO.	IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES	05/06/1998
K132691	RADIOMETER MEDICAL APS	ABL90 FLEX	11/13/2014
K170882	Radiometer Medical ApS	ABL90 FLEX, ABL90 FLEX PLUS	04/28/2017
K983071	RESPIRONICS, INC.	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	03/04/1999
K010052	RESPIRONICS, INC.	RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER	03/19/2001
K040174	ROCHE DIAGNOSTICS CORP.	BILIRUBIN ASSAY ON THE OMNI S ANALYZER	05/14/2004
K110277	SIEMENS HEALTHCARE DIAGNOSTICS	RAPIDPOINT 405 NEONATAL BILIRUBIN	08/15/2011
K073537	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS	NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265	06/27/2008
K994438	SPECTRX, INC.	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	02/04/2000