The following data is part of a premarket notification filed by Immuno-products Industries with the FDA for Anti Ndna Immunoflourescent Test Sys.
| Device ID | K810981 |
| 510k Number | K810981 |
| Device Name: | ANTI NDNA IMMUNOFLOURESCENT TEST SYS |
| Classification | System, Test, Systemic Lupus Erythematosus |
| Applicant | IMMUNO-PRODUCTS INDUSTRIES 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 | 1981-04-13 |
| Decision Date | 1981-04-29 |