The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Strep A Oia.
| Device ID | K915758 |
| 510k Number | K915758 |
| Device Name: | STREP A OIA |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK Boulder, CO 80301 |
| Contact | Lyndal K Hesterberg |
| Correspondent | Lyndal K Hesterberg BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK Boulder, CO 80301 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-23 |
| Decision Date | 1992-01-30 |