FDA Product Code LKJ: Antinuclear Antibody, Antigen, Control
Leading manufacturers include Bio-Rad, Diagnostic Products Corp. and Phadia AB.
50
Total
50
Cleared
88d
Avg days
1983
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Antinuclear Antibody, Antigen, Control Devices (Product Code LKJ)
50 devices
Cleared
Jul 27, 2022
EliA Ro52, EliA Ro60
Phadia AB
Immunology
488d
Cleared
Jan 17, 2003
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
Bio-Rad
Immunology
25d
Cleared
Jan 17, 2003
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
Bio-Rad
Immunology
25d
Cleared
Jan 13, 2003
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
Bio-Rad
Immunology
21d
Cleared
Jan 10, 2003
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
Bio-Rad
Immunology
18d
Cleared
Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
Diagnostic Products Corp.
Immunology
45d
Cleared
Dec 22, 1998
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
Bio-Rad
Immunology
6d
Cleared
Dec 22, 1998
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
Bio-Rad
Immunology
6d
Cleared
Dec 22, 1998
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
Bio-Rad
Immunology
6d
Cleared
Dec 22, 1998
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
Bio-Rad
Immunology
6d
Cleared
Dec 22, 1998
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
Bio-Rad
Immunology
6d
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.