STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204

Test, Natriuretic Peptide

NANOGEN, INC.

The following data is part of a premarket notification filed by Nanogen, Inc. with the FDA for Statusfirst Chf (congestive Heart Failure) Nt-probnp, Model 20204.

Pre-market Notification Details

Device IDK051596
510k NumberK051596
Device Name:STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
ClassificationTest, Natriuretic Peptide
Applicant NANOGEN, INC. 10398 PACIFIC CENTER CT. San Diego,  CA  92121 -4340
ContactVan N Schramm
CorrespondentVan N Schramm
NANOGEN, INC. 10398 PACIFIC CENTER CT. San Diego,  CA  92121 -4340
Product CodeNBC  
CFR Regulation Number862.1117 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-16
Decision Date2006-03-13
Summary:summary

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