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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K001032
Device Name RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
Applicant
OTSUKA PHARMACEUTICAL CO., LTD.
2440 RESEARCH BLVD.
ROCKVILLE,  MD  20850
Applicant Contact JAMES W HARRIS
Correspondent
OTSUKA PHARMACEUTICAL CO., LTD.
2440 RESEARCH BLVD.
ROCKVILLE,  MD  20850
Correspondent Contact JAMES W HARRIS
Regulation Number862.1175
Classification Product Code
CHH  
Date Received03/30/2000
Decision Date 07/24/2000
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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