STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204— 510(k) K051596

Name: FDA 510(k) clearance K051596
Creator: U.S. Food and Drug Administration
Published: 2006-03-13

Substantially Equivalent

Nanogen, Inc.

FDA 510(k) clearance K051596 for STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204, Substantially Equivalent on 2006-03-13. Applicant: Nanogen, Inc.. Device class: 2.

Clearance details

Applicant: Nanogen, Inc.
Product code: Code NBC
Device class: Class 2
Regulation: 21 CFR 862.1117
Advisory panel: Clinical Chemistry
Date received: 2005-06-16
Decision date: 2006-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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