Cleared Traditional

LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY

K921421 · Pro-Lab, Inc. · Microbiology

Jul 1992

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K921421 is an FDA 510(k) clearance for the LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY, a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II — Special Controls, product code LHL), submitted by Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA). The FDA issued a Cleared decision on July 28, 1992, 126 days after receiving the submission on March 24, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K921421 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1992
Decision Date	July 28, 1992
Days to Decision	126 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