The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Autoimmune Test 1/2/3 System.
| Device ID | K833119 |
| 510k Number | K833119 |
| Device Name: | AUTOIMMUNE TEST 1/2/3 SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | ATLANTIC ANTIBODIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-13 |
| Decision Date | 1983-11-21 |