The following data is part of a premarket notification filed by Icl Scientific with the FDA for Proactivator C3, C4 And C3.
| Device ID | K790059 |
| 510k Number | K790059 |
| Device Name: | PROACTIVATOR C3, C4 AND C3 |
| Classification | Complement C3b Activator Immunoassay Reagents |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTP |
| CFR Regulation Number | 866.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-09 |
| Decision Date | 1979-03-15 |