The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Clearview Advanced Strep A , Model 737-430.
| Device ID | K091489 |
| 510k Number | K091489 |
| Device Name: | CLEARVIEW ADVANCED STREP A , MODEL 737-430 |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Contact | Erin E Kenaley |
| Correspondent | Erin E Kenaley BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-20 |
| Decision Date | 2009-09-04 |
| Summary: | summary |