510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DHCClass II

System, Test, Systemic Lupus Erythematosus

21 CFR 866.5820 / Immunology
FDA source (opens on fda.gov)

DHC is the FDA product code for System, Test, Systemic Lupus Erythematosus, a class II device type, regulated under 21 CFR 866.5820. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DHC
Device name
System, Test, Systemic Lupus Erythematosus
Regulation
21 CFR 866.5820
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
16
Ingested recalls
1

Clearances, product code DHC

By decision year
16 clearances under product code DHC with a decision year between 1979 and 2001, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DHC by decision year
YearClearances
19793
19803
19812
19821
19871
19891
19911
19932
20012

Applicants with the most clearances

Product code DHC
Applicants holding the most 510(k) clearances under product code DHC
ApplicantClearances
Cordis US Corp.2
Corgenix, Inc.2
Icl Scientific2
Armkel, LLC1
Biologics Intl., Inc.1
Elias U.S.A., Inc.1
General Biometrics, Inc.1
Immuno-Products Industries1
Immunostics, Inc.1
Lipogen, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code