Cleared Traditional

LEGIONELLA IGG/IGM ELISA TEST SYSTEM

K963318 · Armkel, LLC · Microbiology

Mar 1997

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K963318 is an FDA 510(k) clearance for the LEGIONELLA IGG/IGM ELISA TEST SYSTEM, a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II — Special Controls, product code LHL), submitted by Armkel, LLC (Frederick, US). The FDA issued a Cleared decision on March 3, 1997, 192 days after receiving the submission on August 23, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K963318 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 1996
Decision Date	March 03, 1997
Days to Decision	192 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

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