MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies Class II
FDA product code MYI covers "System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
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 |