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510(k) K061742

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2006
Date Received
June 20, 2006
Clearance Type
Special
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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