ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

Test, Natriuretic Peptide

BAYER HEALTHCARE, LLC

The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Advia Centaur B-type Natriuretic Peptide (bnp) Assay.

Pre-market Notification Details

Device IDK031038
510k NumberK031038
Device Name:ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
ClassificationTest, Natriuretic Peptide
Applicant BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactKenneth T Edds
CorrespondentKenneth T Edds
BAYER HEALTHCARE, LLC 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeNBC  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1117 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-01
Decision Date2003-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414598024 K031038 000
00630414598000 K031038 000
00630414597980 K031038 000
00630414472836 K031038 000
00630414472829 K031038 000
00630414472805 K031038 000
00630414294032 K031038 000
00630414472799 K031038 000
00630414598017 K031038 000

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