PATHFAST NTPROBNP AND D-DIMER TESTS

Test, Natriuretic Peptide

MITSUBISHI KAGAKU IATRON

The following data is part of a premarket notification filed by Mitsubishi Kagaku Iatron with the FDA for Pathfast Ntprobnp And D-dimer Tests.

Pre-market Notification Details

Device IDK072189
510k NumberK072189
Device Name:PATHFAST NTPROBNP AND D-DIMER TESTS
ClassificationTest, Natriuretic Peptide
Applicant MITSUBISHI KAGAKU IATRON 701 FIFTH AVENUE FLOOR 42 Seattle,  WA  98104
ContactHelen Landicho
CorrespondentHelen Landicho
MITSUBISHI KAGAKU IATRON 701 FIFTH AVENUE FLOOR 42 Seattle,  WA  98104
Product CodeNBC  
CFR Regulation Number862.1117 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-06
Decision Date2008-02-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987595301636 K072189 000

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