TRU LEGIONELLA
FDA 510(k) clearance K113190 · decided 2012-02-24
Clearance details
- K-number
- K113190
- Device name
- TRU LEGIONELLA
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-31
- Decision date
- 2012-02-24
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- MJH
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (K191184) | Ssi Diagnostica A/S | 2020-03-05 |
| TRU Legionella (K163273) | Meridian Bioscience, Inc. | 2017-02-21 |
| SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (K061496) | Sa Scientific , Ltd. | 2007-06-28 |
| MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 (K070522) | Inverness Medical Professional Diagnostics | 2007-03-15 |
| LEGIONELLA PNEUMOPHILA IGG/IGM (K033051) | Trinity Biotech USA | 2003-11-26 |
| BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (K991074) | Intracel Corp. | 1999-12-21 |
| BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 (K982238) | Binax, Inc. | 1998-08-21 |
| BINAX LEGIONELLA URINARY ANTIGEN EIA (K934965) | Binax, Inc. | 1994-09-20 |
| LEGIONELLA STAT IGG/IGM TEST KIT (K911356) | Whittaker Bioproducts, Inc. | 1992-07-30 |
Recalls involving this device
No recalls on record reference this clearance.