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510(k) K021622

Device
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
Applicant
Hill-Rom Air-Shields
510(k) number
K021622
Product code
MQM
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-01
Date received
2002-05-16
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
N

Applicant Contact#

Contact
MONICA FERRANTE
Address
330 Jacksonville Rd. Hatboro PA US 19040 19040

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170882ABL90 FLEX, ABL90 FLEX PLUSRadiometer Medical Aps2017-04-28
K132691ABL90 FLEXRadiometer Medical Aps2014-11-13
K133175DRAEGER JAUNDICE METER JM-105Draeger Medical Systems, Inc.2014-11-13
K110277RAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare Diagnostics2011-08-15
K073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265Siemens Medical Solutions Diagnostics2008-06-27
K042522JAUNDICE METER, MODEL JM 103Draeger Medical Infant Care, Inc.2005-07-06
K040174BILIRUBIN ASSAY ON THE OMNI S ANALYZERRoche Diagnostics Corp.2004-05-14
K001687COLORMATE TLC BILITEST SYSTEMChromatics Color Sciences Intl., Inc.2001-09-13
K010052RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZERRespironics, Inc.2001-03-19
K994438BILICHEK NON-INVASIVE BILIRUBIN ANALYZERSpectrx, Inc.2000-02-04
K983071BILICHEK NON-INVASIVE BILIRUBIN ANALYZERRespironics, Inc.1999-03-04
K983134NBILAbbott Laboratories1998-09-23
K972309JM-102 JAUNDICE METERAir-Shields, Inc.1998-09-22
K980646IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLESInstrumentation Laboratory CO1998-05-06
K964590COLORMATE IIIChromatics Color Sciences Intl., Inc.1997-07-24