510(k) K991074
- Device
- BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
- Applicant
- INTRACEL CORP.
- 510(k) number
- K991074
- Product code
- MJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-12-21
- Date received
- 1999-03-31
- Regulation
- 866.3300
- Classification name
- Legionella, Spp., Elisa
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHERYL RUPPEL
- Address
- 1330 Piccard Dr. Rockville MD US 20850 20850
FDA Registration Numbers#
- 9611882
- 3002800697
- 3003750284
- 1221359
- 3007361513
- 1645225
- 3003268355
- 1318354
- 3017662853
- 1924669
- 8010096
- 2029372
- 3043196750
- 2245285
- 3005984081
- 1524213
- 3007118747
Source Documents#
Other 510(k) Records For Product Code MJH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | Ssi Diagnostica A/S | 2020-03-05 |
| K163273 | TRU Legionella | Meridian Bioscience, Inc. | 2017-02-21 |
| K113190 | TRU LEGIONELLA | Meridian Bioscience, Inc. | 2012-02-24 |
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | Sa Scientific , Ltd. | 2007-06-28 |
| K070522 | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | Inverness Medical Professional Diagnostics | 2007-03-15 |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | Trinity Biotech USA | 2003-11-26 |
| K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 | Binax, Inc. | 1998-08-21 |
| K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA | Binax, Inc. | 1994-09-20 |
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | Whittaker Bioproducts, Inc. | 1992-07-30 |
Legacy Summary#
summary
FDA Review#
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