The following data is part of a premarket notification filed by Icl Scientific with the FDA for Systemic Lupus.
| Device ID | K790257 |
| 510k Number | K790257 |
| Device Name: | SYSTEMIC LUPUS |
| Classification | System, Test, Systemic Lupus Erythematosus |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHC |
| CFR Regulation Number | 866.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-06 |
| Decision Date | 1979-03-15 |