The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Seratest Dna Determination.
| Device ID | K842563 |
| 510k Number | K842563 |
| Device Name: | SERATEST DNA DETERMINATION |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Daniel E.walker |
| Correspondent | Daniel E.walker SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-02 |
| Decision Date | 1984-10-25 |