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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 K991927
Device Name MEDI-TEST COMBI 11
Applicant
Macherey-Nagel-Duren
7475 Wisconsin Ane
Suite 850
Bethesda,  MD  20814
Applicant Contact EDUARDO MARCH
Correspondent
Macherey-Nagel-Duren
7475 Wisconsin Ane
Suite 850
Bethesda,  MD  20814
Correspondent Contact EDUARDO MARCH
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMT   JRE   LJX  
Date Received06/08/1999
Decision Date 09/17/1999
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
Recalls CDRH Recalls
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