The following data is part of a premarket notification filed by Bioware Products with the FDA for K/k (asma/ana) Universal Biopak.
| Device ID | K802299 |
| 510k Number | K802299 |
| Device Name: | K/K (ASMA/ANA) UNIVERSAL BIOPAK |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | BIOWARE PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-19 |
| Decision Date | 1981-01-29 |