510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LJMClass II

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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

LJM is the FDA product code for Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a class II device type, regulated under 21 CFR 866.5100. As of , FDA records hold 112 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
LJM
Device name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
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
112
Ingested recalls
2

Clearances, product code LJM

By decision year
112 clearances under product code LJM with a decision year between 1982 and 2018, 1994 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code LJM by decision year
YearClearances
19821
19831
19844
19853
19861
19876
19882
19895
19903
19911
19925
19934
199417
199511
199614
19971
19983
19994
20007
20012
20021
20032
20045
20052
20091
20131
20143
20161
20181

Applicants with the most clearances

Product code LJM
Applicants holding the most 510(k) clearances under product code LJM
ApplicantClearances
Elias U.S.A., Inc.16
American Laboratory Products Company6
Biohytech International, Inc.6
Theratest Laboratories, Inc.6
Zeus Scientific LLC6
Lipogen, Inc.5
David A. Fuccillo, Ph.D.4
Orgentec4
Helix Diagnostics, Inc.3
Immco Diagnostics, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order