The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Ana Test Kit.
| Device ID | K811022 |
| 510k Number | K811022 |
| Device Name: | ANA TEST KIT |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IMMUNO-DIAGNOSTIC PRODUCTS, INC. MD |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-15 |
| Decision Date | 1981-04-23 |