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

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K983134 ABBOTT LABORATORIES 1920 HURD DR.
IRVING TX 75038
K972309 AIR-SHIELDS, INC. 12300 TWINBROOK PKWY.
ROCKVILLE MD 20852
K964590 CHROMATICS COLOR SCIENCES INTL., INC. 16809 BRIARDALE RD.
ROCKVILLE MD 20855
K001687 CHROMATICS COLOR SCIENCES INTL., INC. 16809 BRIARDALE RD.
ROCKVILLE MD 20855
K042522 DRAEGER MEDICAL INFANT CARE, INC. 330 JACKSONVILLE RD.
HATBORO PA 19040
K133175 DRAEGER MEDICAL SYSTEMS, INC. 3135 QUARRY RD.
TELFORD PA 18969
K021622 HILL-ROM AIR-SHIELDS 330 JACKSONVILLE RD.
HATBORO PA 19040
K980646 INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE.
LEXINGTON MA 02173
K922770 LEICA, INC. 203 EGGERT RD.
BUFFALO NY 14215
K132691 RADIOMETER MEDICAL APS AKANDEVEJ 21
BRONSHOJ DK-2700
K170882 Radiometer Medical ApS Aakandevej 21
Broenshoej DK-2700
K983071 RESPIRONICS, INC. 1501 ARDMORE BLVD.
PITTSBURGH PA 15221-4401
K010052 RESPIRONICS, INC. 125 CHASTAIN MEADOW COURT
KENNESAW GA 30144-3724
K040174 ROCHE DIAGNOSTICS CORP. 9115 HAGUE ROAD
INDIANAPOLIS IN 46256
K110277 SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE
NORWOOD MA 02062
K073537 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 2 EDGEWATER DR.
NORWOOD MA 02062
K994438 SPECTRX, INC. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760




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