LKJ · Class II · 21 CFR 866.5100

FDA Product Code LKJ: Antinuclear Antibody, Antigen, Control

Leading manufacturers include Bio-Rad, Zeus Scientific, Inc. and Elias U.S.A., Inc..

50
Total
50
Cleared
88d
Avg days
1983
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Antinuclear Antibody, Antigen, Control Devices (Product Code LKJ)

50 devices
1–24 of 50
Cleared Jul 27, 2022
EliA Ro52, EliA Ro60
K210902
Phadia AB
Immunology · 488d
Cleared Jul 09, 2012
ANA-SCREEN WITH MDSS
K113610
Bio-Rad Laboratories
Immunology · 216d
Cleared Dec 20, 2004
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
K041658
Bio-Rad Laboratories, Inc.
Immunology · 185d
Cleared Oct 08, 2004
ATHENA MULTI-LYTE ANA-II TEST SYSTEM
K042416
Zeus Scientific, Inc.
Immunology · 31d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
K024218
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
K024232
Bio-Rad
Immunology · 25d
Cleared Jan 13, 2003
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
K024223
Bio-Rad
Immunology · 21d
Cleared Jan 10, 2003
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
K024226
Bio-Rad
Immunology · 18d
Cleared Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257
Diagnostic Products Corp.
Immunology · 45d
Cleared Apr 24, 2002
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
K021103
Zeus Scientific, Inc.
Immunology · 19d
Cleared Dec 10, 2001
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
K011244
Zeus Scientific, Inc.
Immunology · 231d
Cleared Oct 25, 1999
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
K993294
Diamedix Corp.
Immunology · 24d
Cleared Dec 22, 1998
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
K984464
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
K984470
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
K984473
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
K984475
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
K984478
Bio-Rad
Immunology · 6d
Cleared Dec 26, 1995
HYTEC AUTOIMMUNE KIT (SS-A)
K954392
Hycor Biomedical, Inc.
Immunology · 98d
Cleared Dec 26, 1995
HYTEC AUTOIMMUNE KITS (SS-B)
K954891
Hycor Biomedical, Inc.
Immunology · 98d
Cleared Sep 24, 1993
SYNELISA CENP-B ANTIBODIES
K931255
Elias U.S.A., Inc.
Immunology · 196d
Cleared Aug 23, 1993
SYLNELISA HISTONE ANTIBODIES
K932302
Elias U.S.A., Inc.
Immunology · 103d
Cleared Dec 01, 1992
SYN ELISA DSDNA ANTIBODIES
K921132
Elias U.S.A., Inc.
Immunology · 266d
Cleared Aug 02, 1989
SERATEST ENA [SCL-70] KIT
K894411
Hemagen Diagnostics, Inc.
Immunology · 16d
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883
Immco Diagnostics, Inc.
Immunology · 44d

About Product Code LKJ - Regulatory Context

510(k) Submission Activity

50 total 510(k) submissions under product code LKJ since 1983, with 50 receiving FDA clearance (average review time: 88 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.