Product code DHC
- Device name
- System, Test, Systemic Lupus Erythematosus
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5820
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K001352 | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2001-04-09 |
| K001398 | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2001-03-30 |
| K930247 | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1993-03-10 |
| K930421 | ELIAS DSDNA ABS | Elias U.S.A., Inc. | 1993-03-10 |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | General Biometrics, Inc. | 1991-12-09 |
| K885048 | ACCESS R-CLONE ANA PROFILE ASSAY | Lipogen, Inc. | 1989-01-24 |
| K872910 | IMMUNO/SLE | Immunostics Co., Inc. | 1987-08-12 |
| K821385 | SERO/TEX LE TEST | Texas Immunology, Inc. | 1982-05-28 |
| K810981 | ANTI NDNA IMMUNOFLOURESCENT TEST SYS | Immuno-Products Industries | 1981-04-29 |
| K810226 | SLE ANTI-N-DNA LATEX TEST | Icl Scientific | 1981-02-09 |
| K800991 | CORDIA N | Cordis Corp. | 1980-05-08 |
| K800992 | CORDIA NP | Cordis Corp. | 1980-05-08 |
| K800605 | ANA LATEX SLIDE TEST | Biologics Intl., Inc. | 1980-04-02 |
| K790106 | IIF-A-N-DNA TEST KIT | Medica Corp. | 1979-03-15 |
| K790257 | SYSTEMIC LUPUS | Icl Scientific | 1979-03-15 |
| K782129 | LUPO-TEC | Armkel, LLC | 1979-03-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850049545907 | AccuDiag ™ | Diagnostic Automation, Inc. | 2023-06-14 |
| 00813545026592 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026585 | MeDiCa | SCIMEDX CORPORATION | 2020-12-01 |
| 00813545026936 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 00813545026929 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 00813545026943 | MeDiCa | SCIMEDX CORPORATION | 2020-11-04 |
| 10722355001729 | Detector Lex SLE | Immunostics Company, Inc | 2016-09-21 |
| 10722355001712 | Detector Lex SLE | Immunostics Company, Inc | 2016-09-21 |
| 00847817018220 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018206 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018282 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018268 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018251 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018244 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018237 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018213 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847817018275 | Autoimmune EIA | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00855360006212 | REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit | CORGENIX MEDICAL CORPORATION | 2016-07-14 |
| 00855360006137 | Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION | 2016-07-14 |
| 00855360006120 | Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION | 2016-07-14 |
| 00816057020195 | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020201 | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020218 | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020225 | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020232 | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020249 | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020256 | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057021604 | ASI SLE Slide Test Control Set | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |