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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K051034
Device Name URYXXON 200 URINE ANALYZER
Applicant
Macherey-Nagel GmbH & Co. KG
7361 Calhoun Pl., Suite 500
Rockville,  MD  20855
Applicant Contact EDUARDO MARCH
Correspondent
Macherey-Nagel GmbH & Co. KG
7361 Calhoun Pl., Suite 500
Rockville,  MD  20855
Correspondent Contact EDUARDO MARCH
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIP   JIR  
JJB   JMA   JMT   KQO   KSL   LJX  
Date Received04/22/2005
Decision Date 11/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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