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

Anti-Rnp Antibody, Antigen And Control

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

LKO is the FDA product code for Anti-Rnp Antibody, Antigen And Control, a class II device type, regulated under 21 CFR 866.5100. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LKO
Device name
Anti-Rnp Antibody, Antigen And 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
23
Ingested recalls
1

Clearances, product code LKO

By decision year
23 clearances under product code LKO with a decision year between 1983 and 2019, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LKO by decision year
YearClearances
19831
19881
19892
19902
19912
19931
19941
19962
19982
19992
20001
20021
20071
20091
20131
20141
20191

Applicants with the most clearances

Product code LKO
Applicants holding the most 510(k) clearances under product code LKO
ApplicantClearances
Euroimmun US Inc.2
General Biometrics, Inc.2
Lipogen, Inc.2
Rhigene, Inc.2
Shield Diagnostics, Ltd.2
Bio-Rad1
Biomedical Diagnostics (Bmd) SA1
Cogent Diagnotics, Ltd.1
Elias U.S.A., Inc.1
Genalyte, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code