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

Antigen, Iha, Cytomegalovirus

21 CFR 866.3175 / Microbiology
FDA source (opens on fda.gov)

LJO is the FDA product code for Antigen, Iha, Cytomegalovirus, a class II device type, regulated under 21 CFR 866.3175. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LJO
Device name
Antigen, Iha, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
12
Ingested recalls
0

Clearances, product code LJO

By decision year
12 clearances under product code LJO with a decision year between 1983 and 2021, 1996 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LJO by decision year
YearClearances
19831
19841
19851
19911
19921
19962
19982
20001
20191
20211

Applicants with the most clearances

Product code LJO
Applicants holding the most 510(k) clearances under product code LJO
ApplicantClearances
Immucor, Inc.3
Akers Research Corp.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Cetus Corp.1
Diamedix Corp.1
Qiagen1
E.I. Dupont de Nemours & Co., Inc.1
Hillcrest Biologicals1
Instrumentation Laboratory Co.1
Sienna Biotech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code