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LKJ — Antinuclear Antibody, Antigen, Control Class II

FDA Device Classification

Classification Details

Product Code
LKJ
Device Class
Class II
Regulation Number
866.5100
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K210902phadiaEliA Ro52, EliA Ro60July 27, 2022
K113610bio-rad laboratoriesANA-SCREEN WITH MDSSJuly 9, 2012
K082759phadia usELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUApril 10, 2009
K081104aesku diagnosticsAESKULISA ANA HEP-2, REF 30-7115USMay 2, 2008
K041658bio-rad laboratoriesBIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODELDecember 20, 2004
K042416zeus scientificATHENA MULTI-LYTE ANA-II TEST SYSTEMOctober 8, 2004
K034013corgenixREAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001January 8, 2004
K030775immuno concepts, n.a.AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUMMay 12, 2003
K024232bio-radLIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113January 17, 2003
K024218bio-radLIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114January 17, 2003
K024223bio-radLIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116January 13, 2003
K024226bio-radLIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116January 10, 2003
K021257diagnostic productsANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)June 3, 2002
K021103zeus scientificMODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEMApril 24, 2002
K011244zeus scientificZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEMDecember 10, 2001
K993294diamedixDIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEMOctober 25, 1999
K984464bio-radLIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211December 22, 1998
K984475bio-radLIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212December 22, 1998
K984478bio-radLIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210December 22, 1998
K984470bio-radLIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209December 22, 1998