Atlas FDA

DHC

16 FDA 510(k) clearances · Product code

43 daysmedian time to decision
331 days90th percentile
16clearances measured

FDA profile

Official device name
System, Test, Systemic Lupus Erythematosus
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5820
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
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 Industries1981-04-29
SLE ANTI-N-DNA LATEX TEST (K810226)Icl Scientific1981-02-09
CORDIA N (K800991)Cordis Corp.1980-05-08
CORDIA NP (K800992)Cordis Corp.1980-05-08
ANA LATEX SLIDE TEST (K800605)Biologics Intl., Inc.1980-04-02
IIF-A-N-DNA TEST KIT (K790106)Medica Corp.1979-03-15
SYSTEMIC LUPUS (K790257)Icl Scientific1979-03-15
LUPO-TEC (K782129)Armkel, LLC1979-03-12

Track DHC automatically

Every clearance here is in the API, with alerts when new ones post.