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510(k) K001032

RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY by Otsuka Pharmaceutical Co., Ltd. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2000
Date Received
March 30, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

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