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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K941314
Device Name STANBIO ALT/GPT (LUQUI-UV) TEST SET
Applicant
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Applicant Contact ALBERT BLANCO
Correspondent
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Correspondent Contact ALBERT BLANCO
Regulation Number862.1030
Classification Product Code
CKA  
Date Received03/18/1994
Decision Date 07/20/1994
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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