The following data is part of a premarket notification filed by Bioware Products with the FDA for Fta-abs Biopak.
| Device ID | K802276 |
| 510k Number | K802276 |
| Device Name: | FTA-ABS BIOPAK |
| Classification | Antigen, Treponema Pallidum For Fta-abs Test |
| Applicant | BIOWARE PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JWL |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-18 |
| Decision Date | 1980-10-23 |