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510(k) K091216

CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 by Siemens Healthcare Diagnostics — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2009
Date Received
April 27, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

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