MJH · Class II · 21 CFR 866.3300

FDA Product Code MJH: Legionella, Spp., Elisa

Leading manufacturers include Binax, Inc., Meridian Bioscience, Inc. and Intracel Corp..

10
Total
10
Cleared
214d
Avg days
1992
Since

FDA 510(k) Cleared Legionella, Spp., Elisa Devices (Product Code MJH)

10 devices
1–10 of 10
Cleared Mar 05, 2020
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K191184
Ssi Diagnostica A/S
Microbiology · 307d
Cleared Feb 21, 2017
TRU Legionella
K163273
Meridian Bioscience, Inc.
Microbiology · 92d
Cleared Feb 24, 2012
TRU LEGIONELLA
K113190
Meridian Bioscience, Inc.
Microbiology · 116d
Cleared Jun 28, 2007
SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
K061496
Sa Scientific , Ltd.
Microbiology · 393d
Cleared Mar 15, 2007
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
K070522
Inverness Medical Professional Diagnostics
Microbiology · 20d
Cleared Nov 26, 2003
LEGIONELLA PNEUMOPHILA IGG/IGM
K033051
Trinity Biotech USA
Microbiology · 58d
Cleared Dec 21, 1999
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
K991074
Intracel Corp.
Microbiology · 265d
Cleared Aug 21, 1998
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
K982238
Binax, Inc.
Microbiology · 57d
Cleared Sep 20, 1994
BINAX LEGIONELLA URINARY ANTIGEN EIA
K934965
Binax, Inc.
Microbiology · 340d
Cleared Jul 30, 1992
LEGIONELLA STAT IGG/IGM TEST KIT
K911356
Whittaker Bioproducts, Inc.
Microbiology · 490d

About Product Code MJH - Regulatory Context