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510(k) K140717

CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT by Siemens Healthcare Diagnostics — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2014
Date Received
March 20, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

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