The following data is part of a premarket notification filed by Icl Scientific with the FDA for Rid System-human C-reactive Protein.
| Device ID | K780325 |
| 510k Number | K780325 |
| Device Name: | RID SYSTEM-HUMAN C-REACTIVE PROTEIN |
| Classification | Alpha-1-t-glycoprotein, Antigen, Antiserum, Control |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DEN |
| CFR Regulation Number | 866.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-27 |
| Decision Date | 1978-03-17 |