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MQM — Bilirubin (Total And Unbound) In The Neonate Test System Class I

FDA Device Classification

Classification Details

Product Code
MQM
Device Class
Class I
Regulation Number
862.1113
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K170882radiometer medical apsABL90 FLEX, ABL90 FLEX PLUSApril 28, 2017
K132691radiometer medical apsABL90 FLEXNovember 13, 2014
K133175draeger medical systemsDRAEGER JAUNDICE METER JM-105November 13, 2014
K110277siemens healthcare diagnosticsRAPIDPOINT 405 NEONATAL BILIRUBINAugust 15, 2011
K073537siemens medical solutions diagnosticsNEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265June 27, 2008
K042522draeger medical infant careJAUNDICE METER, MODEL JM 103July 6, 2005
K040174roche diagnosticsBILIRUBIN ASSAY ON THE OMNI S ANALYZERMay 14, 2004
K021622hill-rom air-shieldsHILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103April 1, 2003
K001687chromatics color sciences intlCOLORMATE TLC BILITEST SYSTEMSeptember 13, 2001
K010052respironicsRESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZERMarch 19, 2001
K994438spectrxBILICHEK NON-INVASIVE BILIRUBIN ANALYZERFebruary 4, 2000
K983071respironicsBILICHEK NON-INVASIVE BILIRUBIN ANALYZERMarch 4, 1999
K983134abbott laboratoriesNBILSeptember 23, 1998
K972309air-shieldsJM-102 JAUNDICE METERSeptember 22, 1998
K980646instrumentation laboratoryIL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLMay 6, 1998
K964590chromatics color sciences intlCOLORMATE IIIJuly 24, 1997
K922770leicaUNISTAT BILIRUBINOMETER MODELS 10310 AND 10311August 18, 1992