The following data is part of a premarket notification filed by Bioware Products with the FDA for T/k (ata/ama) Universal Biopak.
| Device ID | K802308 |
| 510k Number | K802308 |
| Device Name: | T/K (ATA/AMA) UNIVERSAL BIOPAK |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | BIOWARE PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-12-01 |