MJH · Class II · 21 CFR 866.3300

FDA Product Code MJH: Legionella, Spp., Elisa

Leading manufacturers include Meridian Bioscience, Inc., Binax, Inc. and Ssi Diagnostica A/S.

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 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