MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies Class II
FDA Device Classification
Classification Details
- Product Code
- MYI
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K140619 | advandx | MECA XPRESSFISH | October 10, 2014 |
| K133851 | alere scarborough | ALERE PBP2A SA/CONS CULTURE COLONY TEST | September 3, 2014 |
| K121905 | alere scarborough | ALERE PBP2A TEST | July 26, 2012 |
| K090301 | binax | BINAXNOW PBP2A TEST, MODEL 890-000 | April 14, 2010 |
| K091766 | binax | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | February 24, 2010 |
| K062864 | mast group | MASTALEX -MRSA, MODEL RST501 | October 18, 2006 |
| K011710 | oxoid | OXOID PBP2 1 LATEX AGGLUTINATION TEST | April 2, 2002 |
| K011400 | denka seiken | MRSA-SCREEN | March 27, 2002 |
| K010858 | id biomedical | VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION | May 24, 2001 |
| K990640 | id biomedical | VELOGENE RAPID MRSA IDENTIFICATION ASSAY | July 9, 1999 |