Cleared Traditional

RLP CHOLESTEROL IMMUNOSEPARATION ASSAY

K991083 · Otsuka Pharmaceutical Co., Ltd. · Chemistry
Aug 1999
Decision
142d
Days
Class 1
Risk

About This 510(k) Submission

K991083 is an FDA 510(k) clearance for the RLP CHOLESTEROL IMMUNOSEPARATION ASSAY, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Otsuka Pharmaceutical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on August 20, 1999, 142 days after receiving the submission on March 31, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K991083 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1999
Decision Date August 20, 1999
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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