The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binaxnow Pbp2a Test, Model 890-000.
| Device ID | K090301 |
| 510k Number | K090301 |
| Device Name: | BINAXNOW PBP2A TEST, MODEL 890-000 |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Applicant | BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Contact | Suzanne Vogel |
| Correspondent | Suzanne Vogel BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Product Code | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2010-04-14 |
| Summary: | summary |