Cleared Traditional

POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO

K854108 · Medical Diagnostic Technologies, Inc. · Microbiology

Nov 1985

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K854108 is an FDA 510(k) clearance for the POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO, 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 November 12, 1985, 35 days after receiving the submission on October 8, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K854108 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 1985
Decision Date	November 12, 1985
Days to Decision	35 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