The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binaxnox Staphylococcus Aureus Test.
| Device ID | K090964 |
| 510k Number | K090964 |
| Device Name: | BINAXNOX STAPHYLOCOCCUS AUREUS TEST |
| Classification | Kit, Screening, Staphylococcus Aureus |
| Applicant | BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Contact | Suzanne M Vogel |
| Correspondent | Suzanne M Vogel BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Product Code | JWX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2009-12-16 |
| Summary: | summary |