The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Enzyme Ana Test System.
| Device ID | K833148 |
| 510k Number | K833148 |
| Device Name: | ENZYME ANA TEST SYSTEM |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | IMMUNO CONCEPTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-15 |
| Decision Date | 1983-11-21 |