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

Test, Antigen, Nuclear, Epstein-Barr Virus

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

LLM is the FDA product code for Test, Antigen, Nuclear, Epstein-Barr Virus, a class I device type, regulated under 21 CFR 866.3235. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LLM
Device name
Test, Antigen, Nuclear, 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
27
Ingested recalls
1

Clearances, product code LLM

By decision year
27 clearances under product code LLM with a decision year between 1984 and 2024, 1989 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code LLM by decision year
YearClearances
19841
19871
19884
19896
19912
19932
19954
19962
19982
19991
20051
20241

Applicants with the most clearances

Product code LLM
Applicants holding the most 510(k) clearances under product code LLM
ApplicantClearances
Zeus Scientific LLC3
Clinical Sciences, Inc.2
Granbio, Inc.2
Gull Laboratories, Inc.2
IMMUNO CONCEPTS, NA, Ltd.2
Ortho Diagnostic Systems, Inc.2
Biokit, S.A.1
Bion Ent., Ltd.1
Trinity Biotech USA1
Diasorin Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code