The following data is part of a premarket notification filed by Diagnostica, Inc. with the FDA for Anti-human Kappa Serum.
| Device ID | K791284 |
| 510k Number | K791284 |
| Device Name: | ANTI-HUMAN KAPPA SERUM |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-10 |
| Decision Date | 1979-11-27 |