FDA 510(k) K140717, Clinitek Novus Automated Urine Chemistry Analyzer, by Siemens Healthcare Diagnostics
FDA 510(k) K140717, Clinitek Novus Automated Urine Chemistry Analyzer, by Siemens Healthcare Diagnostics
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)
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