Helix Diagnostics, Inc.
Medical device manufacturer in West Sacramento, CA.
15510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K001900 | Enzyme Immunoassay Anti-Ssdna Antibody TestLRM · Traditional | 09/11/2000SE |
| K000489 | Enzyme Immunoassay Anti-Centromere Antibody TestLLL · Traditional | 04/05/2000SE |
| K980337 | Diamedix Immunosimplicity Ana (Is-Ana) Screen Test SystemLJM · Traditional | 05/12/1998SE |
| K960091 | Enzyme Immunoassay Anti-Double Stranded DNA (Dsdna) Test KitLRM · Traditional | 03/20/1996SE |
| K954723 | Enzyme Immunoassay Ana Screening Test KitLKJ · Traditional | 12/15/1995SE |
| K954700 | Enzyme Immunoassay Lupus Screen Test KitLKJ · Traditional | 12/15/1995SE |
| K952253 | Enzyme Immunoassay Ena Plus Screening Test KitLLL · Traditional | 08/24/1995SE |
| K951850 | Enzyme Immunoassay ANTI-JO-1 Antibody Test KitLJM · Traditional | 07/18/1995SE |
| K951798 | Enzyme Immunoassay ANTI-SCI-70 Antibody Test KitLJM · Traditional | 07/17/1995SE |
| K940588 | Enzyme Immunoassay Anti-Sm/Rnp Antibody Test KitLKO · Traditional | 04/20/1994SE |
| K940510 | Enzyme Immunoassay Anti-Sm Antibody Test KitLKP · Traditional | 04/20/1994SE |
| K932850 | Enzyme Immonoassay Extractable Nuclear AntigenLLL · Traditional | 09/24/1993SE |
| K932419 | Anti-Ss-B/La Antibody TestLLL · Traditional | 08/05/1993SE |
| K931495 | Enzyme Immunoassay Anti-Ss-A/Ro Antibody Test KitLLL · Traditional | 07/16/1993SE |
| K913041 | Anti-Dsdna Antibody TestLLL · Traditional | 11/05/1991SE |