Cleared Traditional

K871328 - DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
(FDA 510(k) Clearance)

K871328 · E.I. Dupont DE Nemours & Co., Inc. · Microbiology

Sep 1987

Decision

152d

Days

Class 2

Risk

K871328 is an FDA 510(k) clearance for the DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT, a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II — Special Controls, product code LHL), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on September 2, 1987, 152 days after receiving the submission on April 3, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K871328 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 1987
Decision Date	September 02, 1987
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

Device Classification

Product Code	LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3300