The following data is part of a premarket notification filed by Biostar, Inc. with the FDA for Strep B Oia.
| Device ID | K936112 |
| 510k Number | K936112 |
| Device Name: | STREP B OIA |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | BIOSTAR, INC. 6655 LOOKOUT RD. Boulder, CO 80301 |
| Contact | Dan W Childers |
| Correspondent | Dan W Childers BIOSTAR, INC. 6655 LOOKOUT RD. Boulder, CO 80301 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-23 |
| Decision Date | 1994-07-06 |