Helix Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | September 11, 2000 |
| K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | April 5, 2000 |
| K980337 | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM | May 12, 1998 |
| K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | March 20, 1996 |
| K954700 | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT | December 15, 1995 |
| K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | December 15, 1995 |
| K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | August 24, 1995 |
| K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | July 18, 1995 |
| K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | July 17, 1995 |
| K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | April 20, 1994 |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | April 20, 1994 |
| K932850 | ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN | September 24, 1993 |
| K932419 | ANTI-SS-B/LA ANTIBODY TEST | August 5, 1993 |
| K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | July 16, 1993 |
| K913041 | ANTI-DSDNA ANTIBODY TEST | November 5, 1991 |