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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 K014032
Device Name OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
Applicant
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Applicant Contact MICHAEL CAMPBELL
Correspondent
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Correspondent Contact MICHAEL CAMPBELL
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Codes
JIT   JJX  
Date Received12/06/2001
Decision Date 02/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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