ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771— 510(k) K090900

Name: FDA 510(k) clearance K090900
Creator: U.S. Food and Drug Administration
Published: 2009-06-01

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K090900 for ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771, Substantially Equivalent on 2009-06-01. Applicant: Siemens Healthcare Diagnostics. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code DKB
Device class: Class 2
Regulation: 21 CFR 862.3200
Advisory panel: Clinical Toxicology
Date received: 2009-04-01
Decision date: 2009-06-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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