LHL · Class II · 21 CFR 866.3300

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

Leading manufacturers include Centers For Disease Control and Prevention, Biodan Medical Systems, Ltd. and Medical Diagnostic Technologies, 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 Jul 28, 1992
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
K921421
Pro-Lab, Inc.
Microbiology · 126d
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
Cleared Oct 14, 1983
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD
K832896
Biodan Medical Systems, Ltd.
Immunology · 52d
Cleared Sep 21, 1982
LEGIONELLA PNEUMOPHILA
K822066
Biodan Medical Systems, Ltd.
Microbiology · 69d
Cleared Sep 08, 1981
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
K812006
Centers For Disease Control and Prevention
Microbiology · 54d
Cleared Sep 08, 1981
LEGIONELLA INDIRECT FLUOR. ANTIBODY
K812007
Centers For Disease Control and Prevention
Microbiology · 54d

About Product Code LHL - Regulatory Context