FDA 510(k) Applications for Medical Device Product Code "MJH"
(Legionella, Spp., Elisa)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K982238 | BINAX, INC. | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 | 08/21/1998 |
| K991074 | INTRACEL CORP. | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | 12/21/1999 |
| K070522 | INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | 03/15/2007 |
| K113190 | MERIDIAN BIOSCIENCE, INC. | TRU LEGIONELLA | 02/24/2012 |
| K163273 | MERIDIAN BIOSCIENCE, INC. | TRU Legionella | 02/21/2017 |
| K061496 | SA SCIENTIFIC LTD. | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | 06/28/2007 |
| K191184 | SSI Diagnostica A/S | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | 03/05/2020 |
| K033051 | TRINITY BIOTECH USA | LEGIONELLA PNEUMOPHILA IGG/IGM | 11/26/2003 |
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