FDA 510(k) Applications for Medical Device Product Code "MYI"
(System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K140619 | ADVANDX, INC. | MECA XPRESSFISH | 10/10/2014 |
| K133851 | ALERE SCARBOROUGH, INC | ALERE PBP2A SA/CONS CULTURE COLONY TEST | 09/03/2014 |
| K121905 | ALERE SCARBOROUGH, INC | ALERE PBP2A TEST | 07/26/2012 |
| K090301 | BINAX, INC. | BINAXNOW PBP2A TEST, MODEL 890-000 | 04/14/2010 |
| K091766 | BINAX, INC. | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | 02/24/2010 |
| K011400 | DENKA SEIKEN'S | MRSA-SCREEN | 03/27/2002 |
| K010858 | ID BIOMEDICAL CORP. | VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION | 05/24/2001 |
| K990640 | ID BIOMEDICAL CORP. | VELOGENE RAPID MRSA IDENTIFICATION ASSAY | 07/09/1999 |
| K062864 | MAST GROUP LTD. | MASTALEX -MRSA, MODEL RST501 | 10/18/2006 |
| K011710 | OXOID, LTD. | OXOID PBP2 1 LATEX AGGLUTINATION TEST | 04/02/2002 |
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