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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 K032437
Device Name CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Po Bx 50457
Indianapolis,  IN  46250
Applicant Contact JENNIFER TRIBBETT
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Po Bx 50457
Indianapolis,  IN  46250
Correspondent Contact JENNIFER TRIBBETT
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMT   JRE   LJX  
Date Received08/07/2003
Decision Date 10/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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