DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL— 510(k) K103360

Name: FDA 510(k) clearance K103360
Creator: U.S. Food and Drug Administration
Published: 2010-12-17

Substantially Equivalent

Siemens Corp.

FDA 510(k) clearance K103360 for DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL, Substantially Equivalent on 2010-12-17. Applicant: Siemens Corp.. Device class: 2.

Clearance details

Applicant: Siemens Corp.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2010-11-16
Decision date: 2010-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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