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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated urinalysis system
510(k) Number K140717
Device Name CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Applicant Contact Susan Tibedo
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
2 EDGEWATER DRIVE
NORWOOD,  MA  02062
Correspondent Contact Susan Tibedo
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIO  
JIR   JIX   JJB   JMT   JRE   LJX  
Date Received03/20/2014
Decision Date 11/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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