Legionella Stat Igg/Igm Test Kit
FDA 510(k) K911356 · Whittaker Bioproducts, Inc.
510(k) numberK911356
Submission
- Device name
- Legionella Stat Igg/Igm Test Kit
- Applicant
- Whittaker Bioproducts, Inc.
Walkersville, MD, US - Received
- March 28, 1991
- Decision date
- July 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K934965 | Binax Legionella Urinary Antigen EiaMJH · Traditional | Binax, Inc. | 09/20/1994SE |
More from Binax, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913212 | 3M Ige Single Point Fast TestDHB · Traditional | 11/22/1991SE |
| K904652 | Lyme Stat M Test KitLSR · Traditional | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | 10/16/1991SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | 09/25/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | 05/07/1991SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | 06/27/1990SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | 01/16/1990SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | 10/16/1989SE |
| K894235 | Eb Vca Stat M Test KitLSE · Traditional | 08/30/1989SE |
Questions and answers
When was Legionella Stat Igg/Igm Test Kit cleared by the FDA?
Legionella Stat Igg/Igm Test Kit (K911356) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 490 days after the submission was received.
What is the product code of K911356?
The FDA product code is MJH – Legionella, Spp., Elisa, a Class II (moderate risk) device regulated under 21 CFR 866.3300.