DIMENSION CHEMISTRY III CALIBRATORY— 510(k) K123321

Name: FDA 510(k) clearance K123321
Creator: U.S. Food and Drug Administration
Published: 2013-02-15

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K123321 for DIMENSION CHEMISTRY III CALIBRATORY, Substantially Equivalent on 2013-02-15. Applicant: Siemens Healthcare Diagnostics. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code JIX
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2012-10-26
Decision date: 2013-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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