RLP CHOLESTEROL IMMUNOSEPARATION ASSAY— 510(k) K991083

Name: FDA 510(k) clearance K991083
Creator: U.S. Food and Drug Administration
Published: 1999-08-20

Substantially Equivalent

Otsuka Pharmaceutical Co., Ltd.

FDA 510(k) clearance K991083 for RLP CHOLESTEROL IMMUNOSEPARATION ASSAY, Substantially Equivalent on 1999-08-20. 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: 1999-03-31
Decision date: 1999-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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