Panels › Immunology › Product code DHC · Class 2
System, Test, Systemic Lupus Erythematosus
Regulation 866.5820
0510(k)s in 12 months (16 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DHC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2001 | K001352 | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. | DHC |
| Mar 30, 2001 | K001398 | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. | DHC |
| Mar 10, 1993 | K930421 | ELIAS DSDNA ABS Elias U.S.A., Inc. | DHC |
| Mar 10, 1993 | K930247 | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE The Binding Site, Ltd. | DHC |
| Dec 9, 1991 | K914801 | IMMUNOWELL DSDNA ANTIBODY TEST General Biometrics, Inc. | DHC |
| Jan 24, 1989 | K885048 | ACCESS R-CLONE ANA PROFILE ASSAY Lipogen, Inc. | DHC |
| Aug 12, 1987 | K872910 | IMMUNO/SLE Immunostics Co., Inc. | DHC |
| May 28, 1982 | K821385 | SERO/TEX LE TEST Texas Immunology, Inc. | DHC |
| Apr 29, 1981 | K810981 | ANTI NDNA IMMUNOFLOURESCENT TEST SYS Immuno-Products Industries | DHC |
| Feb 9, 1981 | K810226 | SLE ANTI-N-DNA LATEX TEST Icl Scientific | DHC |
| May 8, 1980 | K800992 | CORDIA NP Cordis Corp. | DHC |
| May 8, 1980 | K800991 | CORDIA N Cordis Corp. | DHC |
| Apr 2, 1980 | K800605 | ANA LATEX SLIDE TEST Biologics Intl., Inc. | DHC |
| Mar 15, 1979 | K790257 | SYSTEMIC LUPUS Icl Scientific | DHC |
| Mar 15, 1979 | K790106 | IIF-A-N-DNA TEST KIT Medica Corp. | DHC |
| Mar 12, 1979 | K782129 | LUPO-TEC Armkel, LLC | DHC |
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