LHL · Class II · 21 CFR 866.3300

FDA Product Code LHL: Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

Leading manufacturers include Medical Diagnostic Technologies, Inc., Zeus Scientific, Inc. and E.I. Dupont DE Nemours & Co., Inc..

18
Total
18
Cleared
92d
Avg days
1981
Since

FDA 510(k) Cleared Reagents, Antibody, Legionella, Direct & Indirect Fluorescent Devices (Product Code LHL)

18 devices
1–18 of 18
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E
K984123
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jun 18, 1997
LEGIONELLA ELISA TEST SYSTEM
K970149
Zeus Scientific, Inc.
Microbiology · 154d
Cleared Mar 03, 1997
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
K963318
Armkel, LLC
Microbiology · 192d
Cleared Sep 02, 1987
DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
K871328
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 152d
Cleared Apr 20, 1987
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
K864006
Medical Diagnostic Technologies, Inc.
Microbiology · 187d
Cleared Nov 12, 1985
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
K854108
Medical Diagnostic Technologies, Inc.
Microbiology · 35d

About Product Code LHL - Regulatory Context