ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
FDA 510(k) K191184 · Ssi Diagnostica A/S
510(k) numberK191184
Submission
- Device name
- ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
- Applicant
- Ssi Diagnostica A/S
Hilleroed, DK - Received
- May 3, 2019
- Decision date
- March 5, 2020
- 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 |
|---|---|---|---|
| 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 |
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | Whittaker Bioproducts, Inc. | 07/30/1992SE |
Questions and answers
When was ImmuView S pneumoniae and L pneumophila Urinary Antigen Test cleared by the FDA?
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (K191184) received a 510(k) decision of Substantially Equivalent on March 5, 2020, 307 days after the submission was received.
What is the product code of K191184?
The FDA product code is MJH – Legionella, Spp., Elisa, a Class II (moderate risk) device regulated under 21 CFR 866.3300.