RLP CHOLESTEROL IMMUNOSEPARATION ASSAY

Enzymatic Esterase--oxidase, Cholesterol

OTSUKA PHARMACEUTICAL CO., LTD.

The following data is part of a premarket notification filed by Otsuka Pharmaceutical Co., Ltd. with the FDA for Rlp Cholesterol Immunoseparation Assay.

Pre-market Notification Details

Device IDK991083
510k NumberK991083
Device Name:RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant OTSUKA PHARMACEUTICAL CO., LTD. 2440 RESEARCH BLVD. Rockville,  MD  20850
ContactJames W Harris
CorrespondentJames W Harris
OTSUKA PHARMACEUTICAL CO., LTD. 2440 RESEARCH BLVD. Rockville,  MD  20850
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-31
Decision Date1999-08-20
Summary:summary

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