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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K032932
Device Name DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
Applicant
Stanbio Laboratory
1261 N. Main St.
Boerne,  TX  78006
Applicant Contact ADAOBI OGUCHI
Correspondent
Stanbio Laboratory
1261 N. Main St.
Boerne,  TX  78006
Correspondent Contact ADAOBI OGUCHI
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Code
JIX  
Date Received09/22/2003
Decision Date 03/10/2004
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
Predetermined Change
Control Plan Authorized		 No
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