SYSTEMIC LUPUS
FDA 510(k) clearance K790257 · decided 1979-03-15
Clearance details
- K-number
- K790257
- Device name
- SYSTEMIC LUPUS
- Applicant
- Icl Scientific
- Decision
- Substantially Equivalent
- Date received
- 1979-02-06
- Decision date
- 1979-03-15
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- DHC
- Device class
- 2
- Regulation number
- 866.5820
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (K001352) | Corgenix, Inc. | 2001-04-09 |
| REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (K001398) | Corgenix, Inc. | 2001-03-30 |
| HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (K930247) | The Binding Site, Ltd. | 1993-03-10 |
| ELIAS DSDNA ABS (K930421) | Elias U.S.A., Inc. | 1993-03-10 |
| IMMUNOWELL DSDNA ANTIBODY TEST (K914801) | General Biometrics, Inc. | 1991-12-09 |
| ACCESS R-CLONE ANA PROFILE ASSAY (K885048) | Lipogen, Inc. | 1989-01-24 |
| IMMUNO/SLE (K872910) | Immunostics Co., Inc. | 1987-08-12 |
| SERO/TEX LE TEST (K821385) | Texas Immunology, Inc. | 1982-05-28 |
| ANTI NDNA IMMUNOFLOURESCENT TEST SYS (K810981) | Immuno-Products Industries | 1981-04-29 |
| SLE ANTI-N-DNA LATEX TEST (K810226) | Icl Scientific | 1981-02-09 |
| CORDIA N (K800991) | Cordis Corp. | 1980-05-08 |
| CORDIA NP (K800992) | Cordis Corp. | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.