DHC — System, Test, Systemic Lupus Erythematosus Class II
FDA product code DHC covers "System, Test, Systemic Lupus Erythematosus", a Class II medical device regulated under 21 CFR 866.5820. Submissions are reviewed by the Immunology panel. At least 16 recent 510(k) clearances have been granted under this product code.
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 |
| K800991 | cordis | CORDIA N | May 8, 1980 |
| K800992 | cordis | CORDIA NP | 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 |