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510(k) K051034

URYXXON 200 URINE ANALYZER by Macherey-Nagel GmbH & Co. KG — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2005
Date Received
April 22, 2005
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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