Product code LKJ— Immunology
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
- Classification name
- Antinuclear Antibody, Antigen, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Total cleared
- 50
- First cleared
- Most recent
Market context for product code LKJ
FDA has cleared devices under product code LKJ between 1983 and 2022, filed by 33 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
last 15 years- 2022
- 2012
- 2009
- 2008
- 2004
- 2003
- 2002
- 2001
- 1999
- 1998
- 1996
- 1995
- 1993
- 1992
- 1991
Top applicants under product code LKJ
Recent clearances under product code LKJ
- K210902 — EliA Ro52, EliA Ro60
- K113610 — ANA-SCREEN WITH MDSS
- K082759 — ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
- K081104 — AESKULISA ANA HEP-2, REF 30-7115US
- K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
- K042416 — ATHENA MULTI-LYTE ANA-II TEST SYSTEM
- K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
- K030775 — AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
- K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
- K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
- K024223 — LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
- K024226 — LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
- K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
- K021103 — MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
- K011244 — ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
- K993294 — DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
- K984464 — LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
- K984470 — LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
- K984473 — LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
- K984475 — LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
- K984478 — LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
- K961815 — QUALITROL ANA CONTROL SERUM SET
- K954392 — HYTEC AUTOIMMUNE KIT (SS-A)
- K954891 — HYTEC AUTOIMMUNE KITS (SS-B)
- K954700 — ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
- K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
- K932876 — DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
- K931255 — SYNELISA CENP-B ANTIBODIES
- K932302 — SYLNELISA HISTONE ANTIBODIES
- K932679 — RHEUMELISA II HISTONE ANTIBODY TEST KIT
- K921132 — SYN ELISA DSDNA ANTIBODIES
- K914454 — THE THERATEST EL-ANA PROFILES
- K913342 — AUTOSTAT(TM) ANTI-DSNA
- K920150 — ENCORE SCL-70
- K914550 — ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
- K912291 — DISTAT ANTI-SCL-70 KIT
- K894411 — SERATEST ENA [SCL-70] KIT
- K893896 — QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
- K893897 — SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
- K885224 — ANA-5 AUTOANTIBODY PROFILE KIT
- K883883 — ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
- K883949 — ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
- K882740 — ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
- K874115 — NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
- K873249 — ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
- K864668 — ANA TEST KIT
- K862313 — KALLESTAD SM/RNP TEST REAGENT
- K842563 — SERATEST DNA DETERMINATION
- K842484 — LEAP LE TEST KIT
- K831463 — ANA-CHECK
Data sourced from openFDA. This site is unofficial and independent of the FDA.