RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY— 510(k) K001032

Name: FDA 510(k) clearance K001032
Creator: U.S. Food and Drug Administration
Published: 2000-07-24

Substantially Equivalent

Otsuka Pharmaceutical Co., Ltd.

FDA 510(k) clearance K001032 for RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY, Substantially Equivalent on 2000-07-24. Applicant: Otsuka Pharmaceutical Co., Ltd.. Device class: 1.

Clearance details

Applicant: Otsuka Pharmaceutical Co., Ltd.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2000-03-30
Decision date: 2000-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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