Cleared Traditional

LEGIONELLA DFA KIT I

K830820 · Bionetic Laboratory Products · Immunology

Jun 1983

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K830820 is an FDA 510(k) clearance for the LEGIONELLA DFA KIT I, a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II — Special Controls, product code LHL), submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 85 days after receiving the submission on March 15, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K830820 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 1983
Decision Date	June 08, 1983
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—

Device Classification

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