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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
510(k) Number K880584
Device Name URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
Applicant
Mach Diag. C/O Wichita State University
Wichita,  KS  67208
Applicant Contact JAMES A JACKSON
Correspondent
Mach Diag. C/O Wichita State University
Wichita,  KS  67208
Correspondent Contact JAMES A JACKSON
Regulation Number862.1785
Classification Product Code
CDM  
Date Received02/10/1988
Decision Date 05/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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