DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A— 510(k) K100778

Name: FDA 510(k) clearance K100778
Creator: U.S. Food and Drug Administration
Published: 2010-05-05

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K100778 for DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A, Substantially Equivalent on 2010-05-05. 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: 2010-03-19
Decision date: 2010-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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