510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LKJClass II

Antinuclear Antibody, Antigen, Control

21 CFR 866.5100 / Immunology
FDA source (opens on fda.gov)

LKJ is the FDA product code for Antinuclear Antibody, Antigen, Control, a class II device type, regulated under 21 CFR 866.5100. As of , FDA records hold 50 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
LKJ
Device name
Antinuclear Antibody, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
50
Ingested recalls
13

Clearances, product code LKJ

By decision year
50 clearances under product code LKJ with a decision year between 1983 and 2022, 1992 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LKJ by decision year
YearClearances
19831
19842
19861
19873
19883
19894
19911
19925
19934
19954
19961
19985
19991
20011
20022
20035
20043
20081
20091
20121
20221

Applicants with the most clearances

Product code LKJ
Applicants holding the most 510(k) clearances under product code LKJ
ApplicantClearances
Bio-Rad9
Elias U.S.A., Inc.3
Zeus Scientific LLC3
Bio-Rad Laboratories Inc.2
Biostar Medical Products, Inc.2
Helix Diagnostics, Inc.2
Hycor Biomedical2
Immco Diagnostics, Inc.2
Phadia AB2
Shield Diagnostics, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code