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510(k) K061846

COMBI SCAN100 by Analyticon Biotechnologies AG — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2007
Date Received
June 26, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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