Cleared Traditional

K864006 - LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
(FDA 510(k) Clearance)

K864006 · Medical Diagnostic Technologies, Inc. · Microbiology

Apr 1987

Decision

187d

Days

Class 2

Risk

K864006 is an FDA 510(k) clearance for the LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST, a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II — Special Controls, product code LHL), submitted by Medical Diagnostic Technologies, Inc. (Augusta, US). The FDA issued a Cleared decision on April 20, 1987, 187 days after receiving the submission on October 15, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K864006 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 1986
Decision Date	April 20, 1987
Days to Decision	187 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