K090301 is an FDA 510(k) clearance for the BINAXNOW PBP2A TEST, MODEL 890-000. This device is classified as a System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II - Special Controls, product code MYI).
Submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on April 14, 2010, 432 days after receiving the submission on February 6, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K090301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2009 |
| Decision Date | April 14, 2010 |
| Days to Decision | 432 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |