DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA— 510(k) K081299

Name: FDA 510(k) clearance K081299
Creator: U.S. Food and Drug Administration
Published: 2008-08-08

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K081299 for DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA, Substantially Equivalent on 2008-08-08. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 2008-05-08
Decision date: 2008-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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