The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Oia Strep A.
| Device ID | K912889 |
| 510k Number | K912889 |
| Device Name: | OIA STREP A |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK Boulder, CO 80301 |
| Contact | Donald L Meyer |
| Correspondent | Donald L Meyer 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 | 1991-07-01 |
| Decision Date | 1991-10-31 |