The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Diamedix Immunosimplicity Ana (is-ana) Screen Test System.
| Device ID | K980337 |
| 510k Number | K980337 |
| Device Name: | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento, CA 95691 -6221 |
| Contact | Virginia L Cappel |
| Correspondent | Virginia L Cappel HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento, CA 95691 -6221 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-28 |
| Decision Date | 1998-05-12 |