Product code DHC— Immunology
ACCESS R-CLONE ANA PROFILE ASSAY
- Classification name
- System, Test, Systemic Lupus Erythematosus
- Device class
- Class 2
- Regulation
- 21 CFR 866.5820
- Advisory panel
- Immunology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code DHC
FDA has cleared devices under product code DHC between 1979 and 2001, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2001
- 1993
- 1991
- 1989
- 1987
- 1982
- 1981
- 1980
- 1979
Top applicants under product code DHC
Recent clearances under product code DHC
- K001352 — REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
- K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
- K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE
- K930421 — ELIAS DSDNA ABS
- K914801 — IMMUNOWELL DSDNA ANTIBODY TEST
- K885048 — ACCESS R-CLONE ANA PROFILE ASSAY
- K872910 — IMMUNO/SLE
- K821385 — SERO/TEX LE TEST
- K810981 — ANTI NDNA IMMUNOFLOURESCENT TEST SYS
- K810226 — SLE ANTI-N-DNA LATEX TEST
- K800991 — CORDIA N
- K800992 — CORDIA NP
- K800605 — ANA LATEX SLIDE TEST
- K790106 — IIF-A-N-DNA TEST KIT
- K790257 — SYSTEMIC LUPUS
- K782129 — LUPO-TEC
Data sourced from openFDA. This site is unofficial and independent of the FDA.