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

510(K) Number: K140717
Device Name: CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS
Device Classification Name: automated urinalysis system
Regulation Number: 862.2900
Classification Product Code: KQO
Date Received: 03/20/2014
Decision Date: 11/17/2014
Regulation Medical Specialty: Clinical Chemistry

1,054 pages (2,513 of 3,567 original pages are fully redacted)