DHC — System, Test, Systemic Lupus Erythematosus Class II
FDA Device Classification
Classification Details
- Product Code
- DHC
- Device Class
- Class II
- Regulation Number
- 866.5820
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K001352 | corgenix | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | April 9, 2001 |
| K001398 | corgenix | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | March 30, 2001 |
| K930247 | binding site | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE | March 10, 1993 |
| K930421 | elias u.s.a | ELIAS DSDNA ABS | March 10, 1993 |
| K914801 | general biometrics | IMMUNOWELL DSDNA ANTIBODY TEST | December 9, 1991 |
| K885048 | lipogen | ACCESS R-CLONE ANA PROFILE ASSAY | January 24, 1989 |
| K872910 | immunostics co | IMMUNO/SLE | August 12, 1987 |
| K821385 | texas immunology | SERO/TEX LE TEST | May 28, 1982 |
| K810981 | immuno-products industries | ANTI NDNA IMMUNOFLOURESCENT TEST SYS | April 29, 1981 |
| K810226 | icl scientific | SLE ANTI-N-DNA LATEX TEST | February 9, 1981 |
| K800992 | cordis | CORDIA NP | May 8, 1980 |
| K800991 | cordis | CORDIA N | May 8, 1980 |
| K800605 | biologics intl | ANA LATEX SLIDE TEST | April 2, 1980 |
| K790106 | medica | IIF-A-N-DNA TEST KIT | March 15, 1979 |
| K790257 | icl scientific | SYSTEMIC LUPUS | March 15, 1979 |
| K782129 | armkel | LUPO-TEC | March 12, 1979 |