The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Strep A.
| Device ID | K863908 |
| 510k Number | K863908 |
| Device Name: | BINAX STREP A |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Contact | David Kelsey |
| Correspondent | David Kelsey BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-07 |
| Decision Date | 1986-12-22 |