Cleared Traditional

CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT

K140717 · Siemens Healthcare Diagnostics · Chemistry
Nov 2014
Decision
242d
Days
Class 1
Risk

About This 510(k) Submission

K140717 is an FDA 510(k) clearance for the CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on November 17, 2014, 242 days after receiving the submission on March 20, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K140717 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2014
Decision Date November 17, 2014
Days to Decision 242 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KQO — Automated Urinalysis System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2900

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