The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Antisera, Rhodamine Conjugated Fragment.
| Device ID | K781951 |
| 510k Number | K781951 |
| Device Name: | ANTISERA, RHODAMINE CONJUGATED FRAGMENT |
| Classification | Fab, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DCE |
| CFR Regulation Number | 866.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-21 |
| Decision Date | 1979-02-16 |