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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dye-Indicator, Ph (Urinary, Non-Quantitative)
510(k) Number K030650
Device Name STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
Applicant
Uridynamics, Inc.
6786 Hawthorne Park Dr.
Indianapolis,  IN  46220
Applicant Contact MYRON RAPKIN
Correspondent
Uridynamics, Inc.
6786 Hawthorne Park Dr.
Indianapolis,  IN  46220
Correspondent Contact MYRON RAPKIN
Regulation Number862.1550
Classification Product Code
CEN  
Subsequent Product Codes
JJW   JRE  
Date Received02/28/2003
Decision Date 04/14/2003
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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