MJH — Legionella, Spp., Elisa Class II
FDA product code MJH covers "Legionella, Spp., Elisa", a Class II medical device regulated under 21 CFR 866.3300. Submissions are reviewed by the Microbiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MJH
- Device Class
- Class II
- Regulation Number
- 866.3300
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191184 | ssi diagnostica | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | March 5, 2020 |
| K163273 | meridian bioscience | TRU Legionella | February 21, 2017 |
| K113190 | meridian bioscience | TRU LEGIONELLA | February 24, 2012 |
| K061496 | sa scientific | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | June 28, 2007 |
| K070522 | inverness medical professional diagnostics | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | March 15, 2007 |
| K033051 | trinity biotech usa | LEGIONELLA PNEUMOPHILA IGG/IGM | November 26, 2003 |
| K991074 | intracel | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | December 21, 1999 |
| K982238 | binax | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELL | August 21, 1998 |
| K934965 | binax | BINAX LEGIONELLA URINARY ANTIGEN EIA | September 20, 1994 |
| K911356 | whittaker bioproducts | LEGIONELLA STAT IGG/IGM TEST KIT | July 30, 1992 |