The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Antisera To Human Free Kappa Chains.
| Device ID | K802283 |
| 510k Number | K802283 |
| Device Name: | ANTISERA TO HUMAN FREE KAPPA CHAINS |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-19 |
| Decision Date | 1980-10-23 |