The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Lupus Screen Test Kit.
| Device ID | K954700 |
| 510k Number | K954700 |
| Device Name: | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT |
| Classification | Antinuclear Antibody, Antigen, Control |
| 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 | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-12 |
| Decision Date | 1995-12-15 |