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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 EAST HOUSTON ST.
SAN ANTONIO,  TX  78202
Applicant Contact WILLIAM J CAMPBELL
Correspondent
STANBIO LABORATORY
2930 EAST 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
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