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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K051121
Device Name DIRECT LDL CHOLESTEROL, MODEL L530-60H
Applicant
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Applicant Contact JIAN VAECHES
Correspondent
Teco Diagnostics
1268 N Lakeview Ave.
Anaheim,  CA  92807
Correspondent Contact JIAN VAECHES
Regulation Number862.1475
Classification Product Code
MRR  
Date Received05/02/2005
Decision Date 08/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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