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510(k) K063276

CLINITEK ADVANTUS, MODEL 1420 by Bayer Healthcare, LLC — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2006
Date Received
October 30, 2006
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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