The following data is part of a premarket notification filed by Icl Scientific with the FDA for Kappa Serum (free & Bound) Anti-human.
| Device ID | K781028 |
| 510k Number | K781028 |
| Device Name: | KAPPA SERUM (FREE & BOUND) ANTI-HUMAN |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | ICL SCIENTIFIC 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 | 1978-06-19 |
| Decision Date | 1978-07-27 |