DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG— 510(k) K092283

Name: FDA 510(k) clearance K092283
Creator: U.S. Food and Drug Administration
Published: 2009-10-21

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K092283 for DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG, Substantially Equivalent on 2009-10-21. Applicant: Siemens Healthcare Diagnostics. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code DFZ
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2009-07-29
Decision date: 2009-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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