CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT— 510(k) K140717

Name: FDA 510(k) clearance K140717
Creator: U.S. Food and Drug Administration
Published: 2014-11-17

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K140717 for CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT, Substantially Equivalent on 2014-11-17. Applicant: Siemens Healthcare Diagnostics. Device class: 1.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code KQO
Device class: Class 1
Regulation: 21 CFR 862.2900
Advisory panel: Clinical Chemistry
Date received: 2014-03-20
Decision date: 2014-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norowood, MA, US

Download summary PDF View on FDA.gov ↗

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