DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA— 510(k) K080578

Name: FDA 510(k) clearance K080578
Creator: U.S. Food and Drug Administration
Published: 2008-05-16

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K080578 for DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA, Substantially Equivalent on 2008-05-16. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code NBC
Device class: Class 2
Regulation: 21 CFR 862.1117
Advisory panel: Clinical Chemistry
Date received: 2008-03-03
Decision date: 2008-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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