The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Biostars Strep A Oia -- Modification.
| Device ID | K922765 |
| 510k Number | K922765 |
| Device Name: | BIOSTARS STREP A OIA -- MODIFICATION |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK Boulder, CO 80301 |
| Contact | Dan W Childers |
| Correspondent | Dan W Childers BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK 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 | 1992-06-02 |
| Decision Date | 1992-08-20 |