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

Antibody Igm, If, Epstein-Barr Virus

21 CFR 866.3235 / Microbiology
FDA source (opens on fda.gov)

LJN is the FDA product code for Antibody Igm, If, Epstein-Barr Virus, a class I device type, regulated under 21 CFR 866.3235. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LJN
Device name
Antibody Igm, If, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
23
Ingested recalls
0

Clearances, product code LJN

By decision year
23 clearances under product code LJN with a decision year between 1983 and 2012, 1988 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LJN by decision year
YearClearances
19831
19871
19884
19892
19902
19912
19922
19931
19941
19981
19992
20041
20051
20081
20121

Applicants with the most clearances

Product code LJN
Applicants holding the most 510(k) clearances under product code LJN
ApplicantClearances
Granbio, Inc.2
IMMUNO CONCEPTS, NA, Ltd.2
Ortho Diagnostic Systems, Inc.2
Quest Intl., Inc.2
Zeus Scientific LLC2
Amico Laboratories, Inc.1
Baxter Diagnostics, Inc.1
Bio-Rad Laboratories Inc.1
Bion Ent., Ltd.1
Diasorin Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code