Bartels Legionella Urinary Antigen Elisa Test
FDA 510(k) K991074 · Intracel Corp.
510(k) numberK991074
Submission
- Device name
- Bartels Legionella Urinary Antigen Elisa Test
- Applicant
- Intracel Corp.
Rockville, MD, US - Received
- March 31, 1999
- Decision date
- December 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJH – Legionella, Spp., Elisa
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3300
- Specialty
- Microbiology
Other 510(k)s with product code MJH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen TestMJH · Traditional | Ssi Diagnostica A/S | 03/05/2020SE |
| K163273 | TRU LegionellaMJH · Special | Meridian Bioscience, Inc. | 02/21/2017SE |
| K113190 | Tru LegionellaMJH · Traditional | Meridian Bioscience, Inc. | 02/24/2012SE |
| K061496 | SAS Legionella Test, SAS Legionella Dipstick TestMJH · Traditional | Sa Scientific , Ltd. | 06/28/2007SE |
| K070522 | Modification to: Binax Now Legionella Urinary Antigen Test, #852-000,852-012MJH · Special | Inverness Medical Professional Diagnostics | 03/15/2007SE |
| K033051 | Legionella Pneumophila Igg/IgmMJH · Traditional | Trinity Biotech USA | 11/26/2003SE |
| K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella…MJH · Traditional | Binax, Inc. | 08/21/1998SE |
| K934965 | Binax Legionella Urinary Antigen EiaMJH · Traditional | Binax, Inc. | 09/20/1994SE |
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | Whittaker Bioproducts, Inc. | 07/30/1992SE |
More from Whittaker Bioproducts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003204 | Bartels Viral Respiratory Screening and Identification KitGNW · Special | 11/07/2000SE |
| K990664 | Prima System - Old, Bartels Elisa - NewLLH · Special | 03/31/1999SE |
| K982311 | Bartels Cinakit CMV AntigenemiaGQH · Traditional | 12/14/1998SE |
| K933878 | Zymmune(Tm) CD4/CD8 Cell Monitoring KitGKZ · Traditional | 11/14/1995SE |
Questions and answers
When was Bartels Legionella Urinary Antigen Elisa Test cleared by the FDA?
Bartels Legionella Urinary Antigen Elisa Test (K991074) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 265 days after the submission was received.
What is the product code of K991074?
The FDA product code is MJH – Legionella, Spp., Elisa, a Class II (moderate risk) device regulated under 21 CFR 866.3300.