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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K091216
Device Name CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
Applicant
Siemens Healthcare Diagnostics
2 Edgewater Dr.
Norowood,  MA  02062
Applicant Contact NOOR MALKI
Correspondent
Siemens Healthcare Diagnostics
2 Edgewater Dr.
Norowood,  MA  02062
Correspondent Contact NOOR MALKI
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JFY   JHI   JIN  
JIP   JIR   JJB   JMT   JRE   KQO  
LJX  
Date Received04/27/2009
Decision Date 10/09/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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