Cleared Traditional

THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E

K984123 · Zeus Scientific, Inc. · Microbiology

Jan 1999

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K984123 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E, a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II — Special Controls, product code LHL), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 11, 1999, 54 days after receiving the submission on November 18, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K984123 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 1998
Decision Date	January 11, 1999
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

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