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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
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