Binax Legionella Urinary Antigen Eia
FDA 510(k) K934965 · Binax, Inc.
510(k) numberK934965
Submission
- Device name
- Binax Legionella Urinary Antigen Eia
- Applicant
- Binax, Inc.
Portland, ME, US - Received
- October 15, 1993
- Decision date
- September 20, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K991074 | Bartels Legionella Urinary Antigen Elisa TestMJH · Traditional | Intracel Corp. | 12/21/1999SE |
| K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella…MJH · Traditional | Binax, Inc. | 08/21/1998SE |
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | Whittaker Bioproducts, Inc. | 07/30/1992SE |
More from Whittaker Bioproducts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090301 | Binaxnow PBP2A Test, Model 890-000MYI · Traditional | 04/14/2010SE |
| K091766 | Clearview Exact PBP2A Test, Model 891-000MYI · Traditional | 02/24/2010SE |
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | 12/16/2009SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | 09/04/2009SE |
| K083744 | Binaxnow Malaria Positive Control Kit, Model 665-010MJZ · Traditional | 09/01/2009SE |
| K092223 | Modification to: Binaxnow Influenza a & B TestPSZ · Special | 08/12/2009SE |
| K080003 | Binaxnow G6PD TestJBF · Traditional | 10/23/2008SE |
| K062109 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/09/2006SE |
| K053126 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/30/2005SE |
| K041049 | Binaxnow Influenza a & B TestPSZ · Traditional | 08/10/2004SE |
Questions and answers
When was Binax Legionella Urinary Antigen Eia cleared by the FDA?
Binax Legionella Urinary Antigen Eia (K934965) received a 510(k) decision of Substantially Equivalent on September 20, 1994, 340 days after the submission was received.
What is the product code of K934965?
The FDA product code is MJH – Legionella, Spp., Elisa, a Class II (moderate risk) device regulated under 21 CFR 866.3300.