FDA Product Code
FDA Product Code DHC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5820
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001352 | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K001398 | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2001-03-30 | Traditional | PDF ↗ |
| K930247 | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1993-03-10 | Traditional | PDF ↗ |
| K930421 | ELIAS DSDNA ABS | Elias U.S.A., Inc. | 1993-03-10 | Traditional | PDF ↗ |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | General Biometrics, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K885048 | ACCESS R-CLONE ANA PROFILE ASSAY | Lipogen, Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K872910 | IMMUNO/SLE | Immunostics Co., Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K821385 | SERO/TEX LE TEST | Texas Immunology, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K810981 | ANTI NDNA IMMUNOFLOURESCENT TEST SYS | Immuno-Products Industries | 1981-04-29 | Traditional | PDF ↗ |
| K810226 | SLE ANTI-N-DNA LATEX TEST | Icl Scientific | 1981-02-09 | Traditional | PDF ↗ |
| K800992 | CORDIA NP | Cordis Corp. | 1980-05-08 | Traditional | PDF ↗ |
| K800991 | CORDIA N | Cordis Corp. | 1980-05-08 | Traditional | PDF ↗ |
| K800605 | ANA LATEX SLIDE TEST | Biologics Intl., Inc. | 1980-04-02 | Traditional | PDF ↗ |
| K790257 | SYSTEMIC LUPUS | Icl Scientific | 1979-03-15 | Traditional | PDF ↗ |
| K790106 | IIF-A-N-DNA TEST KIT | Medica Corp. | 1979-03-15 | Traditional | PDF ↗ |
| K782129 | LUPO-TEC | Armkel, LLC | 1979-03-12 | Traditional | PDF ↗ |
Product code DHC · Class II · Immunology. Data: openFDA.