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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 K061559
Device Name ACON URINALYSIS REAGENT STRIPS
Applicant
ACON LABORATORIES CO.
4139 GARDENDALE CENTER
# 101
SAN ANTONIO,  TX  78229
Applicant Contact MARTIN O'CONNOR
Correspondent
ACON LABORATORIES CO.
4139 GARDENDALE CENTER
# 101
SAN ANTONIO,  TX  78229
Correspondent Contact MARTIN O'CONNOR
Regulation Number862.1785
Classification Product Code
CDM  
Subsequent Product Codes
CEN   JIL   JIN   JIO   JIR  
JJB   JMA   JMT   JRE   LJX  
Date Received06/05/2006
Decision Date 08/11/2006
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
Recalls CDRH Recalls
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