LLM · Class I · 21 CFR 866.3235

FDA Product Code LLM: Test, Antigen, Nuclear, Epstein-barr Virus

Leading manufacturers include Biokit, S.A..

27
Total
27
Cleared
234d
Avg days
1984
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 272d recently vs 232d historically

FDA 510(k) Cleared Test, Antigen, Nuclear, Epstein-barr Virus Devices (Product Code LLM)

27 devices
1–24 of 27
Cleared Aug 07, 2024
ADVIA Centaur EBV-EBNA IgG
K233605
Biokit, S.A.
Microbiology · 272d

About Product Code LLM - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code LLM since 1984, with 27 receiving FDA clearance (average review time: 234 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under LLM have taken an average of 272 days to reach a decision - up from 232 days historically. Manufacturers should account for longer review timelines in current project planning.

LLM devices are reviewed by the Microbiology panel. Browse all Microbiology devices →