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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Berthelot Indophenol, Urea Nitrogen
510(k) Number K893128
Device Name STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
Applicant
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Applicant Contact WILLIAM J CAMPBELL
Correspondent
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Correspondent Contact WILLIAM J CAMPBELL
Regulation Number862.1770
Classification Product Code
CDL  
Date Received04/25/1989
Decision Date 07/25/1989
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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