System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
FDA product code MYI · Class II (moderate risk) · 21 CFR 866.1640 · Microbiology
10510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140619 | Meca XpressfishMYI · Traditional | Advandx, Inc. | 10/10/2014SE |
| K133851 | Alere PBP2A Sa/Cons Culture Colony TestMYI · Traditional | Alere Scarborough, Inc. | 09/03/2014SE |
| K121905 | Alere PBP2A TestMYI · Special | Alere Scarborough, Inc. | 07/26/2012SE |
| K090301 | Binaxnow PBP2A Test, Model 890-000MYI · Traditional | Binax, Inc. | 04/14/2010SE |
| K091766 | Clearview Exact PBP2A Test, Model 891-000MYI · Traditional | Binax, Inc. | 02/24/2010SE |
| K062864 | Mastalex -Mrsa, Model RST501MYI · Traditional | Mast Group , Ltd. | 10/18/2006SE |
| K011710 | Oxoid PBP2 1 Latex Agglutination TestMYI · Traditional | Oxoid , Ltd. | 04/02/2002SE |
| K011400 | Mrsa-ScreenMYI · Traditional | Denka Seiken'S | 03/27/2002SE |
| K010858 | Velogene Genomic Identification Assay for Mrsa with One-Step DetectionMYI · Traditional | Id Biomedical Corp. | 05/24/2001SE |
| K990640 | Velogene Rapid Mrsa Identification AssayMYI · Traditional | Id Biomedical Corp. | 07/09/1999SE |