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510(k) K023885

COMBI-SCREEN, MODELS 10SL AND 11SL by Analyticon Biotechnologies AG — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2003
Date Received
November 21, 2002
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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