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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 K033610
Device Name HDL-CHOLESTEROL PLUS 2ND GENERATION
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact SHERRI L COENEN
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact SHERRI L COENEN
Regulation Number862.1475
Classification Product Code
LBS  
Date Received11/17/2003
Decision Date 12/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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