The following data is part of a premarket notification filed by Icl Scientific with the FDA for Anti-human C1 Inhibitor Serum (goat).
| Device ID | K781017 |
| 510k Number | K781017 |
| Device Name: | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBA |
| CFR Regulation Number | 866.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-16 |
| Decision Date | 1978-08-14 |